Manufacturer

Sonosite

United StatesLegal entities : Fujifilm Sonosite, Inc.

Markets : Austria · Belgium · Denmark · Finland · France · Germany · Italy · Netherlands · Norway · Poland · Spain · United States

Approvals : EU – class I, IIa · United States (FDA) – 510(k) : 48 · class II · latest in 2026 · see on the FDA website

Public contracts won : France 14 · Germany 3

EU representative : Fujifilm Sonosite B.V. (Netherlands)

Website

9 categories, 194 models including 88 on the market, 1 country

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On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
Click a category to see competitors, a model to open its EUDAMED record.

Category	EMDN code	Registered models	Class	Contact
Ultrasound scanners - hardware accessories - other	Z1104018099	AC-DC POWER SUPPLY, SONOSITE iLOOK AC/DC Power Adapter4 refs Battery Charger93/42 BATTERY CHARGER, 2-BAY, IVIZ Battery P18438-023 refs 53 others Battery P30205-013 refs BATTERY PACK ASSEMBLY, 6 CELL, LITHIUM-ION, M-TURBO5 refs93/42 BATTERY PACK ASSEMBLY, 6 CELL, LITHIUM-ION, TURBO S3 refs93/42 ECG Cable Assembly and Module P06917-513 refs Edge Mini-Dock5 refs93/42 Edge Stand P15800-5593/42 Edge Stand P17313-1593/42 iLOOK M-Turbo Mini-Dock5 refs93/42 Power Park13 refs Sonosite iLOOK SonoSite M-Turbo93/42 SonoSite Microphone Accessory2 refs Sonosite MT I/O Hub Sonosite MT Power Supply Sonosite MT TTC Sonosite ST Stand Head2 refs SonoSite Stand3 refs Sonosite ZX Stand4 refs Sonosite ZX Stand Head2 refs Triple Transducer Connect8 refs AXOTRACK I STERILE PROCEDURE KIT (18G XTW)93/42 (no longer marketed) AxoTrack I Sterile Procedure Kit CASE, SINGLE KIT, 18GA, AXOTRACK, STERILE93/42 (no longer marketed) AxoTrack I Sterile Procedure Kit CASE, SINGLE KIT, 21GA, AXOTRACK, STERILE93/42 (no longer marketed) Battery P27003-2093/42 (no longer marketed) Battery P27003-2193/42 (no longer marketed) Battery P27003-2393/42 (no longer marketed) Battery P31051-0193/42 (no longer marketed) BATTERY PACK ASSEMBLY, 6 CELL, LITHIUM-ION, EDGE2 refs93/42 (no longer marketed) BATTERY PACK ASSEMBLY, 6 CELL, LITHIUM-ION, JANUS MOUNTABLE93/42 (no longer marketed) BATTERY PACK ASSEMBLY, 6 CELL, LITHIUM-ION, TURBO S INDIA93/42 (no longer marketed) BATTERY, PHOENIX, MOLICEL M35A93/42 (no longer marketed) CASE OF AXOTRACK® I STERILE PROCEDURE KIT (21G TW)93/42 (no longer marketed) Edge Stand P30382-0193/42 (no longer marketed) H-Universal Stand P12163-1393/42 (no longer marketed) H-Universal Stand P15800-2693/42 (no longer marketed) H-Universal Stand P30377-0193/42 (no longer marketed) Power Pack P13122-0293/42 (no longer marketed) Power Pack P13559-0593/42 (no longer marketed) Power Pack P13559-0693/42 (no longer marketed) SERVICE EXCHANGE, SONOSITE PX STAND HEAD, 2.093/42 (no longer marketed) SII Stand2 refs93/42 (no longer marketed) SonoSite LX93/42 (no longer marketed) Sonosite PX2 refs93/42 (no longer marketed) Sonosite PX Stand93/42 (no longer marketed) Sonosite PX Stand Head93/42 (no longer marketed) SONOSITE PX STAND HEAD, 2.093/42 (no longer marketed) SONOSITE ST STAND HEAD, 1.02 refs93/42 (no longer marketed) SONOSITE ST STAND, 1.093/42 (no longer marketed) Sonosite ZX Stand Head STAND HEAD, SONOSITE ZX 1.093/42 (no longer marketed) TRIPLE TRANSDUCER CONNECT, QUICK RELEASE NON D2 COMPATIBLE7 refs93/42 (no longer marketed) TRIPLE TRANSDUCER CONNECT, S-SERIES NON D2 COMPATIBLE5 refs93/42 (no longer marketed) V-Universal Stand P12738-3193/42 (no longer marketed)	I, IIa MDR, 93/42	EUDAMED record Report an error
Two-dimensional linear-array transcutaneous ultrasound probes	Z110402010101	L15-5 TRANSDUCER, SONOSITE iLOOK L38x/10-5 MHz TRANSDUCER, L38XI/10-5 MHZ5 refs TRANSDUCER, HFL38X/13-6 MHZ7 refs93/42 TRANSDUCER, HFL38XI/13-6 MHZ3 refs TRANSDUCER, HFL38XP/13-6 MHZ5 refs93/42 37 others TRANSDUCER, HFL50X/15-6 MHZ3 refs TRANSDUCER, HFL50XP/15-6 MHZ4 refs93/42 TRANSDUCER, HSL25X/13-6 MHZ3 refs TRANSDUCER, HSL25XP/13-6 MHZ4 refs93/42 TRANSDUCER, L12-35 refs TRANSDUCER, L13-65 refs TRANSDUCER, L15-45 refs TRANSDUCER, L19-58 refs TRANSDUCER, L25V 13-6 MHZ, IVIZ4 refs93/42 TRANSDUCER, L25X/13-6 MHZ3 refs TRANSDUCER, L25XP/13-6 MHZ7 refs93/42 TRANSDUCER, L38V 10-5 MHZ, IVIZ6 refs93/42 TRANSDUCER, L38XP/10-5 MHZ7 refs93/42 TRANSDUCER, SLAX/13-6 MHZ11 refs93/42 TRANSDUCER, T8-33 refs UHF22 Transducer UHF22: 22 MHZ ULTRA HIGH-FREQUENCY CLINICAL TRANSDUCER4 refs93/42 UHF48 Transducer UHF48: 48 MHZ ULTRA HIGH-FREQUENCY CLINICAL TRANSDUCER4 refs93/42 UHF70 Transducer UHF70: 70 MHZ ULTRA HIGH-FREQUENCY CLINICAL TRANSDUCER6 refs93/42 Edge Stand P15800-1693/42 (no longer marketed) Edge Stand P15800-2193/42 (no longer marketed) Edge Stand P15800-2593/42 (no longer marketed) Edge Stand P15800-5093/42 (no longer marketed) H-Universal Stand P12163-5093/42 (no longer marketed) L25n/13-6 MHz TRANSDUCER, L25N-128/13-6 MHZ, NANOMAXX7 refs93/42 (no longer marketed) SII Stand93/42 (no longer marketed) Sonosite PX Stand3 refs93/42 (no longer marketed) Sonosite PX Stand Head2 refs93/42 (no longer marketed) TRANSDUCER, C60N/5-2 MHZ, NANOMAXX93/42 (no longer marketed) TRANSDUCER, C60X/5-2 MHZ2 refs93/42 (no longer marketed) TRANSDUCER, HFL50XP/15-6 MHZ, ROHS93/42 (no longer marketed) TRANSDUCER, L15-4, MPS93/42 (no longer marketed) TRANSDUCER, L25E/13-6 MHZ4 refs93/42 (no longer marketed) TRANSDUCER, L38E/10-5 MHZ7 refs93/42 (no longer marketed) TRANSDUCER, L38N/10-5 MHZ, NANOMAXX7 refs93/42 (no longer marketed) TRANSDUCER, P21X/5-1 MHZ93/42 (no longer marketed) TRANSDUCER, SLA/13-6 MHZ93/42 (no longer marketed) V-Universal Stand P12738-5093/42 (no longer marketed)	I, IIa MDR, 93/42	EUDAMED record Report an error
Curvilinear transcutaneous two-dimensional ultrasound probes (convex-array)	Z110402010201	L38xi/10-5 MHz Armored TRANSDUCER, RC60XI/5-2 MHZ3 refs TRANSDUCER, C10-35 refs TRANSDUCER, C11X/8-5 MHZ3 refs TRANSDUCER, C11XP/8-5 MHZ5 refs93/42 TRANSDUCER, C35X/8-3 MHZ3 refs 23 others TRANSDUCER, C35XP/8-3 MHZ2 refs93/42 TRANSDUCER, C5-16 refs TRANSDUCER, C60X/5-2 MHZ9 refs93/42 TRANSDUCER, C60XF/5-2 MHZ7 refs93/42 TRANSDUCER, C60XI/5-2 MHZ6 refs93/42 TRANSDUCER, C60XP/5-2 MHZ4 refs93/42 TRANSDUCER, IC10-38 refs TRANSDUCER, ICTX/8-5 MHZ3 refs TRANSDUCER, ICTXP/9-5 MHZ3 refs C60x/5-2 MHz TRANSDUCER, C60XI/5-2 MHZ2 refs93/42 (no longer marketed) Sonosite PX Stand93/42 (no longer marketed) Sonosite PX Stand Head93/42 (no longer marketed) TRANSDUCER, C11N/8-5 MHZ, NANOMAXX6 refs93/42 (no longer marketed) TRANSDUCER, C35XP/8-3 MHZ,UDI93/42 (no longer marketed) TRANSDUCER, C60E/5-2 MHZ6 refs93/42 (no longer marketed) TRANSDUCER, C60N/5-2 MHZ, NANOMAXX6 refs93/42 (no longer marketed) TRANSDUCER, C60V 5-2 MHZ, IVIZ3 refs93/42 (no longer marketed) TRANSDUCER, C8X/8-5 MHZ CURVED ARRAY93/42 (no longer marketed) TRANSDUCER, C8X/8-5 MHZ CURVED ARRAY, COAX CABLE4 refs93/42 (no longer marketed) TRANSDUCER, HFL50X/15-6 MHZ (no longer marketed) TRANSDUCER, HFL50XP/15-6 MHZ2 refs93/42 (no longer marketed) TRANSDUCER, P21X/5-1 MHZ93/42 (no longer marketed) TRANSDUCER, P21XP/5-1 MHZ93/42 (no longer marketed)	I, IIa MDR, 93/42	EUDAMED record Report an error
Portable ultrasound scanners	Z11040103	Battery P25000-153 refs Battery P27852-0393/42 iLOOK ULTRASOUND SYSTEM SonoSite Edge II13 refs SonoSite iViz11 refs93/42 19 others SonoSite LX3 refs SonoSite M-Turbo35 refs93/42 Sonosite MT2 refs SonoSite SII22 refs Sonosite ST3 refs SonoSite X-Porte21 refs93/42 Sonosite ZX Portable System3 refs VEVO MD IMAGING SYSTEM (120V)6 refs93/42 VEVO MD IMAGING SYSTEM (240V)2 refs93/42 FC1 Ultrasound System93/42 (no longer marketed) SonoSite Edge3 refs93/42 (no longer marketed) SONOSITE EDGE II ULTRASOUND SYSTEM, 4.193/42 (no longer marketed) SonoSite M-Turbo M-TURBO ULTRASOUND SYSTEM, 3.093/42 (no longer marketed) SonoSite M-Turbo M-TURBO ULTRASOUND SYSTEM, 4.193/42 (no longer marketed) SonoSite NanoMaxx2 refs93/42 (no longer marketed) SONOSITE PX ULTRASOUND SYSTEM, 3.1.193/42 (no longer marketed) SonoSite S-Series2 refs93/42 (no longer marketed) SONOSITE SII ULTRASOUND SYSTEM, 4.193/42 (no longer marketed) SonoSite X-Porte X-PORTE ENGINE, CW, BLDK993/42 (no longer marketed)	IIa MDR, 93/42	EUDAMED record Report an error
Transcutaneous ultrasound sector probes (phased array), two-dimensional	Z110402010301	D2XP/2 MHz UHF70: 70 MHZ ULTRA HIGH-FREQUENCY CLINICAL TRANSDUCER93/42 TRANSDUCER, P10X/8-4 MHZ3 refs TRANSDUCER, P10XP/8-4 MHZ4 refs93/42 TRANSDUCER, P11-35 refs TRANSDUCER, P21V 5-1 MHZ, IVIZ9 refs93/42 12 others TRANSDUCER, P21X/5-1 MHZ5 refs93/42 TRANSDUCER, P21XP/5-1 MHZ4 refs93/42 TRANSDUCER, P5-19 refs Transducer, rP19x/5-1 MHz Armored3 refs TRANSDUCER, RP19XP/5-1 MHZ3 refs93/42 P11x/10-5 MHz TRANSDUCER P11X/10-5 MD MEDTECH WITH AXO-TRACK2 refs93/42 (no longer marketed) P11x/10-5 MHz TRANSDUCER P11X/10-5 SOMA WITH AXO-TRACK2 refs93/42 (no longer marketed) P21n/5-1 MHz TRANSDUCER, P21V 5-1 MHZ, IVIZ93/42 (no longer marketed) TRANSDUCER, P17/5-1 MHZ WITH BIOPSY93/42 (no longer marketed) TRANSDUCER, P17/5-1 MHZ, BIOPSY COMPATIBLE2 refs93/42 (no longer marketed) TRANSDUCER, P21N/5-1 MHZ, NANOMAXX9 refs93/42 (no longer marketed) TRANSDUCER, P21XP/5-1 MHZ, ROH93/42 (no longer marketed)	IIa MDR, 93/42	EUDAMED record Report an error
Transesophageal ultrasound probes, two-dimensional	Z1104020301	TRANSDUCER, TEEXI/8-3 MHZ3 refs	IIa MDR	EUDAMED record Report an error
Endocavitary ultrasound probes, two-dimensional No model still on the market	Z1104020201	Edge Stand P15800-2793/42 (no longer marketed) Edge Stand P15800-2893/42 (no longer marketed) H-Universal Stand P12163-1493/42 (no longer marketed) H-Universal Stand P12163-1693/42 (no longer marketed) H-Universal Stand P12163-1793/42 (no longer marketed) 17 others H-Universal Stand P12163-2093/42 (no longer marketed) ICTx/8-5 MHz TRANSDUCER, ICTN/8-5 MHZ, NANOMAXX2 refs93/42 (no longer marketed) SII Stand93/42 (no longer marketed) SonoSite iViz3 refs93/42 (no longer marketed) TRANSDUCER, HFL50XP/15-6 MHZ93/42 (no longer marketed) TRANSDUCER, HSL25XP/13-6 MHZ2 refs93/42 (no longer marketed) TRANSDUCER, ICTN/8-5 MHZ, NANOMAXX3 refs93/42 (no longer marketed) TRANSDUCER, ICTXP/9-5 MHZ5 refs93/42 (no longer marketed) TRANSDUCER, L38E/10-5 MHZ2 refs93/42 (no longer marketed) TRANSDUCER, L38V 10-5 MHZ, IVIZ3 refs93/42 (no longer marketed) UHF22 Transducer UHF22: 22 MHZ ULTRA HIGH-FREQUENCY CLINICAL TRANSDUCER2 refs93/42 (no longer marketed) UHF48 Transducer UHF48: 48 MHZ ULTRA HIGH-FREQUENCY CLINICAL TRANSDUCER2 refs93/42 (no longer marketed) UHF70 Transducer UHF70: 70 MHZ ULTRA HIGH-FREQUENCY CLINICAL TRANSDUCER2 refs93/42 (no longer marketed) V-Universal Stand P12738-3393/42 (no longer marketed) V-Universal Stand P12738-3493/42 (no longer marketed) V-Universal Stand P12738-3693/42 (no longer marketed) V-Universal Stand P12738-4093/42 (no longer marketed)	I, IIa 93/42	EUDAMED record Report an error
Transcutaneous ultrasound sector probes (phased array), multidimensional No model still on the market	Z110402010302	TRANSDUCER, T8-393/42 (no longer marketed)	IIa 93/42	EUDAMED record Report an error
Transesophageal ultrasound probes, multidimensional No model still on the market	Z1104020302	TRANSDUCER, TEEXP/8-3 MHZ2 refs93/42 (no longer marketed)	IIa 93/42	EUDAMED record Report an error

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