The following data is part of a premarket notification filed by Konica Minolta, Inc with the FDA for Skr 3000.
| Device ID | K162504 |
| 510k Number | K162504 |
| 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 Fukuo |
| Correspondent | Russell D. Munves STORCH AMINI & MUNVES 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 | 2016-09-07 |
| Decision Date | 2016-10-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04560141945821 | K162504 | 000 |
| 04560141945753 | K162504 | 000 |