Manufacturer

Siemens Medical Solutions USA

United StatesLegal entities : Siemens Medical Solutions USA Inc., Siemens Medical Solutions USA, Inc.

Markets : Belgium · Denmark · Finland · France · Germany · Greece · Italy · Netherlands · Portugal · Spain · Sweden · United States

Approvals : EU – class IIa, IIb · United States (FDA) – 510(k) : 877 · PMA : 4 · class I, II, III · latest in 2026 · see on the FDA website

EU representative : Siemens Healthcare GmbH (Germany)

Website contact@siemens-healthineers.com

19 categories, 109 models including 106 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
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Category	EMDN code	Registered models	Class	Contact
Two-dimensional linear-array transcutaneous ultrasound probes	Z110402010101	10L4 Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_10L4_10787114 11L4 Transducer MDD_07_IIA_IQH_ERL NH127A_ACDV_11L4_1136158493/42 11L4 Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_11L4_11284844 12L3 Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_12L3_11575183 12L4 Transducer MDD_07_IIA_IQH_ERL NH127A_ACDV_12L4_1078603593/42 25 others 13L4 Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_13L4_11361589 14L4 Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_14L4_11503732 14L4a Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_14L4a_11711446 14L5 Transducer MDD_07_IIA_IQH_ERL NH127A_ACDV_14L5_1078939693/42 14L5 Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_14L5_11254090 15L4 Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_15L4_11289427 16L4 Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_16L4_11284846 18H5 Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_18H5_11284924 18H6 Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_18H6_11289567 18L6 Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_18L6_11575184 18L6HD Transducer MDD_07_IIA_IQH_ERL NH127A_ACDV_18L6HD_1078940093/42 7L2 Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_7L2_11289562 9L4 Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_9L4_10789393 HLX Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_HLX_11575216 L10-5v Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_L10-5v_11319682 L13-5 Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_L13-5_11004329 L17-5 Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_L17-5_11004318 L8-3 Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_L8-3_11004317 VF10-5 Transducer MDD_07_IIA_IQH_ERL NH127A_ACDV_VF10-5_1078938793/42 VF10-5 Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_VF10-5_10136142 VF12-4 Transducer MDD_07_IIA_IQH_ERL NH127A_ACDV_VF12-4_1157518693/42 VF13-5 Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_VF13-5_10789372 VF16-5 Transducer MDD_07_IIA_IQH_ERL NH127A_ACDV_VF16-5_1078504193/42 VF16-5 Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_VF16-5_11014552 VF13-5 Transducer MDD_07_IIA_IQH_ERL NH127A_ACDV_VF13-5_1078938893/42 (no longer marketed)	IIa MDR, 93/42	EUDAMED record Report an error
Curvilinear transcutaneous two-dimensional ultrasound probes (convex-array)	Z110402010201	11M2 Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_11M2_11653755 11M3 Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_11M3_11284923 4C1 Transducer MDD_07_IIA_IQH_ERL NH127A_ACDV_4C1_1078449793/42 5C1 Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_5C1_11268278 5C1 Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_5C1_11291794 14 others 5C1a Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_5C1a_11711957 6C1 HD Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_6C1HD_11575181 6C1 Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_6C1_11503481 7C2 Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_7C2_11268277 8C3 HD Transducer MDD_07_IIA_IQH_ERL NH127A_ACDV_8C3HD_1013594393/42 9C2 Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_9C2_11503103 9C3 Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_9C3_11575182 C5-2 Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_C5-2_11003875 C5-2v Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_C5-2v_11711157 CH5-2 Transducer MDD_07_IIA_IQH_ERL NH127A_ACDV_CH5-2_1078938693/42 CH5-2 Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_CH5-2_10136141 DAX Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_DAX_10787116 6C2 Transducer MDD_07_IIA_IQH_ERL NH127A_ACDV_6C2_1078449893/42 (no longer marketed) EV9-4 Transducer MDD_07_IIA_IQH_ERL NH127A_ACDV_EV9-4_1078938493/42 (no longer marketed)	IIa MDR, 93/42	EUDAMED record Report an error
Transcutaneous ultrasound sector probes (phased array), two-dimensional	Z110402010301	10V4 Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_10V4_08266709 10V4 Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_10V4_11014579 10V4 Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_10V4_11319697 4P1 Transducer MDD_07_IIA_IQH_ERL NH127A_ACDV_4P1_1078939893/42 4V1 Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_4V1_11014576 12 others 4V1c Transducer MDD_07_IIA_IQH_ERL NH127A_ACDV_4V1c_1013594793/42 4V1c Transducer MDD_07_IIA_IQH_ERL NH127A_ACDV_4V1c_1078449693/42 4V1c Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_4V1c_07695724 5P1 Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_5P1_11014154 5V1 Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_5V1_11291796 8V3 Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_8V3_10789382 8V3 Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_8V3_11014578 8V4 Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_8V4_11284847 P4-2 Transducer MDD_07_IIA_IQH_ERL NH127A_ACDV_P4-2_1078938593/42 P4-2 Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_P4-2_10136143 P8-4 Transducer MDD_07_IIA_IQH_ERL NH127A_ACDV_P8-4_1078938993/42 P8-4 Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_P8-4_11014543	IIa MDR, 93/42	EUDAMED record Report an error
Endocavitary ultrasound probes, two-dimensional	Z1104020201	10BCC3 Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_10BCC3_11712408 10EV3 transducer MDR_07_IIA_IQH_BTS LB A_ACDV_10EV3_11502928 10MC3 Transducer MDD_07_IIA_IQH_ERL NH127A_ACDV_10MC3_1128484293/42 10MC3 Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_10MC3_11268679 9EC4 Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_9EC4_10787117 3 others 9MC3 Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_9MC3_11284920 EC9-4 Transducer MDD_07_IIA_IQH_ERL NH127A_ACDV_EC9-4_1078938393/42 EC9-4 Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_EC9-4_10136144	IIa MDR, 93/42	EUDAMED record Report an error
Internal ultrasound scanners	Z11040101	ACUSON Juniper Diagnostic Ultrasound System MDR_07_IIA_IQH_BTS LB A_ACDV_Juniper_11335791 ACUSON Juniper Select Diagnostic Ultrasound System MDR_07_IIA_IQH_BTS LB A_ACDV_Juniper Select_11653093 ACUSON Maple Diagnostic Ultrasound System MDR_07_IIA_IQH_BTS LB A_ACDV_Maple_11711750 ACUSON Maple Select Diagnostic Ultrasound System MDR_07_IIA_IQH_BTS LB A_ACDV_Maple Select_11711779 ACUSON Origin Diagnostic Ultrasound System MDR_07_IIA_IQH_BTS LB A_ACDV_Origin_11668590_116694002 refs 2 others ACUSON Redwood Diagnostic Ultrasound System MDR_07_IIA_IQH_BTS LB A_ACDV_Redwood_11503314 ACUSON Sequoia Diagnostic Ultrasound System MDR_07_IIA_IQH_BTS LB A_ACDV_Sequoia_11148775_116586352 refs	IIa MDR	EUDAMED record Report an error
Picture archiving and communication systems	Z110603	MI View&GO Image Processing Software_10_IIa_HES3 refs Symbia.net combination MDR_SPPP_10_IIA_HES_Comb.Workstation Symbia.net Nuclear Medicine Workstation_10_IIa_HES	IIa MDR	EUDAMED record Report an error
Transesophageal ultrasound probes, two-dimensional	Z1104020301	5VT Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_5VT_11370949 V5Ms Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_V5Ms_11013704_110137052 refs V7M Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_V7M_10855905	IIa MDR	EUDAMED record Report an error
CT/gamma camera systems	Z11020201	Symbia Intevo 16 Combination MDR_SPPP_10_IIb_HES_Comb.SPECT-CT3 refs Symbia Pro.specta Q3 SPECT-CT_10_IIb_HES3 refs	IIb MDR	EUDAMED record Report an error
CT/PET systems	Z11020301	Biograph Horizon - 3R Combination MDR_SPPP_11_IIb_HES_Comb.PET-CT3 refs Biograph Horizon-3R PET-CT_11_IIb_HES3 refs	IIb MDR	EUDAMED record Report an error
Curvilinear transcutaneous multidimensional ultrasound probes (convex-array)	Z110402010202	7VC2 Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_7VC2_11289565 9VC2 Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_9VC2_11575443	IIa MDR	EUDAMED record Report an error
Endocavitary ultrasound probes, multidimensional	Z1104020202	9VE4 Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_9VE4_11289564 9VE4 Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_9VE4_11575444	IIa MDR	EUDAMED record Report an error
Fixed station gamma cameras with multiple heads - with ‘total body’ acquisition	Z11020105	Symbia Evo Excel combination MDR_SPPP_10_IIa_HES_Comb.SPECT3 refs Symbia S Series SPECT_10_IIa_HES3 refs	IIa MDR	EUDAMED record Report an error
Portable ultrasound scanners	Z11040103	ACUSON Freestyle Diagnostic Ultrasound System MDR_07_IIA_IQH_BTS LB A_ACDV_Freestyle_11002300 ACUSON P500 Diagnostic Ultrasound System MDR_07_IIA_IQH_BTS LB A_ACDV_P500_10785577_117130642 refs	IIa MDR	EUDAMED record Report an error
Positron emission tomography instruments - consumables	Z11020485	ASM ACCEL LINE SRCS Sealed Radioactive Sources_10_IIb_HES3 refs CS-20-1 Uniform Phantom Combi MDR_SPPP_11_IIb_HES_Comb.Sources3 refs	IIb MDR	EUDAMED record Report an error
Transcutaneous ultrasound sector probes (phased array), multidimensional	Z110402010302	4Z1c Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_4Z1c_10789391 5Z1 Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_5Z1_11290766	IIa MDR	EUDAMED record Report an error
Transesophageal ultrasound probes, multidimensional	Z1104020302	Z6Ms Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_Z6Ms_11575187 Z6T Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_Z6T_11151267	IIa MDR	EUDAMED record Report an error
Ultrasound probes - other	Z11040299	2.0CW Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_CW2_10789380 5.0CW Transducer MDR_07_IIA_IQH_BTS LB A_ACDV_CW5_10789381	IIa MDR	EUDAMED record Report an error
Cardiology ultrasound scanners	Z11040102	ACUSON SC2000 Diagnostic Ultrasound System MDR_07_IIA_IQH_BTS LB A_ACDV_SC2000_10433816	IIa MDR	EUDAMED record Report an error
Ultrasound scanners - hardware accessories - other	Z1104018099	syngo SC2000 Workplace MDR_07_IIA_IQH_BTS LB A_ACDV_SC2000 Workplace_10433921	IIa MDR	EUDAMED record Report an error

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