The following data is part of a premarket notification filed by Konica Minolta Medical & Graphic, Inc. with the FDA for Direct Digitizer, Regius Model 110.
| Device ID | K071181 |
| 510k Number | K071181 |
| Device Name: | DIRECT DIGITIZER, REGIUS MODEL 110 |
| 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 | 2007-04-30 |
| Decision Date | 2007-05-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04560141936737 | K071181 | 000 |
| 04560141936706 | K071181 | 000 |
| 04560141936690 | K071181 | 000 |
| 04560141925564 | K071181 | 000 |
| 04560141921788 | K071181 | 000 |