The following data is part of a premarket notification filed by Konica Minolta, Inc. with the FDA for Skr 3000.
| Device ID | K223267 |
| 510k Number | K223267 |
| Device Name: | SKR 3000 |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | Konica Minolta, INC. 1 Sakura-machi Hino-shi, JP 191-8511 |
| Contact | Tsutomu Fukui |
| Correspondent | Jan Maniscalco Konica Minolta Healthcare Americas, Inc. 411 Newark Pompton Turnpike Wayne, NJ 07470 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-10-24 |
| Decision Date | 2022-11-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04560141950795 | K223267 | 000 |
| 04560141950788 | K223267 | 000 |
| 04560141950771 | K223267 | 000 |