The following data is part of a premarket notification filed by Orex Computed Radiography Ltd with the FDA for Pccr Digital Imaging Device.
| Device ID | K003256 |
| 510k Number | K003256 |
| Device Name: | PCCR DIGITAL IMAGING DEVICE |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | OREX COMPUTED RADIOGRAPHY LTD 49 PLAIN ST. North Attleboro, MA 02760 |
| Contact | Rosina Robinson |
| Correspondent | Rosina Robinson OREX COMPUTED RADIOGRAPHY LTD 49 PLAIN ST. North Attleboro, MA 02760 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-10-17 |
| Decision Date | 2000-11-08 |