The following data is part of a premarket notification filed by Philips Medical Systems, Inc. with the FDA for Philips Bucky Vision.
| Device ID | K982795 |
| 510k Number | K982795 |
| Device Name: | PHILIPS BUCKY VISION |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | PHILIPS MEDICAL SYSTEMS, INC. 710 BRIDGEPORT AVE. Shelton, CT 06484 -4708 |
| Contact | Peter Altman |
| Correspondent | Peter Altman PHILIPS MEDICAL SYSTEMS, INC. 710 BRIDGEPORT AVE. Shelton, CT 06484 -4708 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-08-10 |
| Decision Date | 1998-11-24 |
| Summary: | summary |