The following data is part of a premarket notification filed by Konica Minolta Medical & Graphic, Inc. with the FDA for Direct Digitizer, Regius Model 210.
| Device ID | K092717 |
| 510k Number | K092717 |
| Device Name: | DIRECT DIGITIZER, REGIUS MODEL 210 |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | KONICA MINOLTA MEDICAL & GRAPHIC, INC. 140 EAST 45TH ST., 25TH FLOOR TWO GRAND CENTRAL TOWER New York, NY 10017 |
| Contact | Russel Munves |
| Correspondent | Russel Munves KONICA MINOLTA MEDICAL & GRAPHIC, INC. 140 EAST 45TH ST., 25TH FLOOR TWO GRAND CENTRAL TOWER New York, NY 10017 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-09-03 |
| Decision Date | 2009-10-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04560141931381 | K092717 | 000 |
| 04560141928411 | K092717 | 000 |
| 04560141928381 | K092717 | 000 |
| 04560141928367 | K092717 | 000 |
| 04560141928350 | K092717 | 000 |
| 04560141928329 | K092717 | 000 |
| 04560141928305 | K092717 | 000 |
| 04560141928282 | K092717 | 000 |
| 04560141928268 | K092717 | 000 |
| 04560141926141 | K092717 | 000 |
| 04560141925557 | K092717 | 000 |
| 04560141925472 | K092717 | 000 |
| 04560141922792 | K092717 | 000 |
| 04560141922747 | K092717 | 000 |
| 04560141930902 | K092717 | 000 |
| 04560141930919 | K092717 | 000 |
| 04560141930926 | K092717 | 000 |
| 04560141931107 | K092717 | 000 |
| 04560141931091 | K092717 | 000 |
| 04560141931084 | K092717 | 000 |
| 04560141931077 | K092717 | 000 |
| 04560141931060 | K092717 | 000 |
| 04560141931053 | K092717 | 000 |
| 04560141931046 | K092717 | 000 |
| 04560141931039 | K092717 | 000 |
| 04560141931022 | K092717 | 000 |
| 04560141930964 | K092717 | 000 |
| 04560141930957 | K092717 | 000 |
| 04560141930940 | K092717 | 000 |
| 04560141930933 | K092717 | 000 |
| 04560141922730 | K092717 | 000 |