The following data is part of a premarket notification filed by Konica Minolta, Inc. with the FDA for Skr 4000.
| Device ID | K191645 |
| 510k Number | K191645 |
| Device Name: | SKR 4000 |
| 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 | Russell D. Munves Storch Amini PC 140 East 45th Street 25th Floor New York, NY 10017 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-19 |
| Decision Date | 2019-08-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04560141947986 | K191645 | 000 |
| 04560141948631 | K191645 | 000 |