The following data is part of a premarket notification filed by Konica Minolta Medical & Graphic, Inc. with the FDA for Regius Unitea.
| Device ID | K071436 |
| 510k Number | K071436 |
| Device Name: | REGIUS UNITEA |
| Classification | System, Image Processing, Radiological |
| Applicant | KONICA MINOLTA MEDICAL & GRAPHIC, INC. 140 EAST 45TH ST., 25TH FLOOR TWO GRAND CENTRAL TOWER New York, NY 10017 |
| Contact | Russell Munves |
| Correspondent | Russell Munves KONICA MINOLTA MEDICAL & GRAPHIC, INC. 140 EAST 45TH ST., 25TH FLOOR TWO GRAND CENTRAL TOWER New York, NY 10017 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-05-23 |
| Decision Date | 2007-06-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04560141944961 | K071436 | 000 |
| 04560141949584 | K071436 | 000 |