The following data is part of a premarket notification filed by Konica Minolta, Inc. with the FDA for Skr 3000.
| Device ID | K210619 |
| 510k Number | K210619 |
| 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. 2217 US Highway 70 E Garner, NC 27529 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-01 |
| Decision Date | 2021-08-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04560141945852 | K210619 | 000 |
| 04560141945814 | K210619 | 000 |
| 04560141945807 | K210619 | 000 |
| 04560141945784 | K210619 | 000 |
| 04560141949294 | K210619 | 000 |
| 04560141949287 | K210619 | 000 |