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Sign in to claim this brandKonica Minolta, Inc.
Japan·JP-MF-000008214
Last updated September 17, 2026
Information
- Country
- Japan
- Address
- 1, Sakura-machi, Tokyo, Japan
- Website
- konicaminolta.com
- —
- —
- [email protected]
- Phone
- —
- PRRC Contact
- Sato Yoshinori
- EUDAMED SRN
- JP-MF-000008214
- FDA FEI Number
- 3004485675
- DUNS Number
- 692076161
Catalogue (192)
Page 4 of 4| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| REGIUS Cassette | A3P3 | FDA UDI | Class II | Active |
| Drypro Sd-Q | A3RD | FDA UDI | Class I | Active |
| C2-6b-D | A7MP | FDA UDI | Class II | Active |
| ImagePilot | V1.93R00E | FDA UDI | Class II | Active |
| AeroDR P-51 | A6C5 | FDA UDI | Class II | Active |
| AeroDR P-52 | A8D7 | FDA UDI | Class II | Active |
| Cs-7 | A4C1 | FDA UDI | Class II | Active |
| Regius Model 110hq | A1YC | FDA UDI | Class II | Active |
| Drypro Sd-S | A76J | FDA UDI | Class I | Active |
| REGIUS Cassette | A3P5 | FDA UDI | Class II | Active |
| Kdr 1717 | A9KX | FDA UDI | Class II | Active |
| P-85 | ADU2 | FDA UDI | Class II | Active |
| Drypro Sigma | A4AA | FDA UDI | Class II | Active |
| Drypro Sd-Q | A3R8 | FDA UDI | Class I | Active |
| Regius Model 110hq | A5RF | FDA UDI | Class II | Active |
| AeroDR Stitching Barrier Unit | A5EX | FDA UDI | Class II | Active |
| P-53 | AEA0 | FDA UDI | Class II | Active |
| Skr 3000 | K241319 | FDA 510(k) | Class II | Active |
| Bone Suppression Software | K240281 | FDA 510(k) | Class II | Active |
| Ultrasound System SONIMAGE HS1 | K162065 | FDA 510(k) | Class II | Active |
| Ultrasound System Sonimage Hs 1 | K152577 | FDA 510(k) | Class II | Active |
| Konicaminolta Di-X1 | K212685 | FDA 510(k) | Class II | Active |
| Skr 4000 | K191645 | FDA 510(k) | Class II | Active |
| Ultrasound System SONIMAGE MX1 | K220993 | FDA 510(k) | Class II | Active |
| Skr 3000 | K162504 | FDA 510(k) | Class II | Active |
| Ultrasound System SONIMAGE HS1 | K182153 | FDA 510(k) | Class II | Active |
| Ultrasound System Sonimage Hs1, Linear Probe L18-4, Convex Probe C5-2 | K142197 | FDA 510(k) | Class II | Active |
| Skr 3000 | K172793 | FDA 510(k) | Class II | Active |
| Konicaminolta DI-X1 | K230906 | FDA 510(k) | Class II | Active |
| Skr 3000 | K182688 | FDA 510(k) | Class II | Active |
| Skr 3000 | K250665 | FDA 510(k) | Class II | Active |
| Ultrasound System SONIMAGE MX1 | K180084 | FDA 510(k) | Class II | Active |
| Aerodr System 2 | K141271 | FDA 510(k) | Class II | Active |
| AeroDR SYSTEM 2 | K151465 | FDA 510(k) | Class II | Active |
| Skr 3000 | K171716 | FDA 510(k) | Class II | Active |
| Skr 3000 | K223267 | FDA 510(k) | Class II | Active |
| Skr 3000 | K210619 | FDA 510(k) | Class II | Active |
| Skr 3000 | K213908 | FDA 510(k) | Class II | Active |
| Ultrasound System SONIMAGE HS1 | K151060 | FDA 510(k) | Class II | Active |
| ImagePilot | K210066 | FDA 510(k) | Class II | Active |
| Konicaminolta DI-X1 | K182431 | FDA 510(k) | Class II | Active |
| Co Pilot/Regius Unitea | K133730 | FDA 510(k) | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
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Notified Bodies
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Authorities
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FDA Recalls (1)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Apr 24, 2017 | Z-2769-2017 | — | terminated | The Doppler velocity measurement on the Sonimage HS1 ultrasound system is not accurate. |