The following data is part of a premarket notification filed by Konica Minolta Inc. with the FDA for Co Pilot/regius Unitea.
| Device ID | K133730 |
| 510k Number | K133730 |
| Device Name: | CO PILOT/REGIUS UNITEA |
| Classification | System, Image Processing, Radiological |
| Applicant | KONICA MINOLTA INC. 140 EAST 45TH ST., 25TH FL TWO GRAND TOWER New York, NY 10017 |
| Contact | Russell Munves |
| Correspondent | Russell Munves KONICA MINOLTA INC. 140 EAST 45TH ST., 25TH FL TWO GRAND 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 | 2013-12-06 |
| Decision Date | 2014-01-31 |
| Summary: | summary |