Manufacturer

Konica Minolta

JapanLegal entities : Konica Minolta, Inc.

Markets : Germany · Netherlands · United States

Approvals : EU – class I, IIa, IIb · United States (FDA) – 510(k) : 31 · class I, II · latest in 2026 · see on the FDA website

EU representative : Konica Minolta Business Solutions Europe GmbH (Netherlands)

17 categories, 51 models including 50 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
Direct digital teleradiographs	Z11031102	SKR 30002 refs SKR 3000, P-532 refs SKR 3000, P-652 refs SKR 3000, P-752 refs SKR 3000, P-822 refs 2 others SKR 3000, P-853 refs SKR 3000, P-953 refs	IIa MDR	EUDAMED record Report an error
Digital computed radiography (cr) systems - hardware accessories	Z11060280	CP1M2002 refs93/42 FP-1S8 refs93/42 RC-3003 refs RP-4L, RP-4T22 refs93/42 RP4S1108 refs93/42 1 other RP6M11012 refs93/42	I, IIa MDR, 93/42	EUDAMED record Report an error
Two-dimensional linear-array transcutaneous ultrasound probes	Z110402010101	LINEAR PROBE HL18-4 LINEAR PROBE L11-3 LINEAR PROBE L14-4 LINEAR PROBE L18-4 LINEAR PROBE WL13-3 1 other LINEAR PROBE X20L	IIa MDR	EUDAMED record Report an error
Internal ultrasound scanners	Z11040101	ULTRASOUND SYSTEM KUS330 ULTRASOUND SYSTEM SONIMAGE HS127 refs93/42 ULTRASOUND SYSTEM SONIMAGE HS23 refs ULTRASOUND SYSTEM SONIMAGE MX12 refs	IIa MDR, 93/42	EUDAMED record Report an error
Laser imagers for bioimaging	Z110705	DRYPRO MODEL 832 DRYPRO MODEL 873 DRYPRO SIGMA2 refs DRYPRO SIGMA 22 refs	I MDR	EUDAMED record Report an error
General purpose X-ray films	Z130101	SD-E3 refs SD-P, SD-PM, SD-Q, SD-QM, SD-Q2, SD-QM2 SD-S, SD-SM Plus3 refs	I MDR	EUDAMED record Report an error
Single-input computed radiography (cr) systems	Z11060201	REGIUS MODEL 110 HQ93/42 REGIUS MODEL 2103 refs93/42 REGIUS SIGMA293/42	IIa 93/42	EUDAMED record Report an error
Ultrasound scanners - hardware accessories - other	Z1104018099	Accessories for KUS3303 refs Accessories for MX13 refs ULTRASOUND SYSTEM SONIMAGE HS23 refs	I MDR	EUDAMED record Report an error
Curvilinear transcutaneous two-dimensional ultrasound probes (convex-array)	Z110402010201	C2-6b-D2 refs93/42 CONVEX PROBE C5-2 CONVEX PROBE MC10-3 (no longer marketed)	IIa MDR, 93/42	EUDAMED record Report an error
Dry thermal printer X-ray films	Z130106	DRYPRO MODEL TH3 refs TR-S3 refs	I MDR	EUDAMED record Report an error
Systems for direct digital radiology (dr) - hardware accessories	Z11031180	SKR 3000, accessories3 refs SKR 40002 refs93/42	I, IIa MDR, 93/42	EUDAMED record Report an error
Systems for direct digital radiology (dr) - medical device software	Z11031192	CS-7 KONICAMINOLTA DI-X1	IIa MDR	EUDAMED record Report an error
Transcutaneous ultrasound sector probes (phased array), two-dimensional	Z110402010301	SECTOR PROBE S4-2 SECTOR PROBE S4-2A	IIa MDR	EUDAMED record Report an error
Endocavitary ultrasound probes, two-dimensional	Z1104020201	ENDOCAVITY PROBE EC9-3	IIa MDR	EUDAMED record Report an error
Multifunctional systems for direct digital radiology	Z11031101	AeroDR X7093/42	IIb 93/42	EUDAMED record Report an error
Picture archiving and communication systems	Z110603	ImagePilot	IIa MDR	EUDAMED record Report an error
Ultrasound probes - other	Z11040299	Accessories for PROBE A7CD	I MDR	EUDAMED record Report an error

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