The following data is part of a premarket notification filed by Omega Medical Imaging, Inc. with the FDA for R650 Qdasm Collimator.
| Device ID | K093572 |
| 510k Number | K093572 |
| Device Name: | R650 QDASM COLLIMATOR |
| Classification | Collimator, Automatic, Radiographic |
| Applicant | OMEGA MEDICAL IMAGING, INC. 675 HICKMAN CIRCLE Sanford, FL 32771 |
| Contact | James Princehorn |
| Correspondent | James Princehorn OMEGA MEDICAL IMAGING, INC. 675 HICKMAN CIRCLE Sanford, FL 32771 |
| Product Code | IZW |
| CFR Regulation Number | 892.1610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-11-18 |
| Decision Date | 2010-02-03 |
| Summary: | summary |