The following data is part of a premarket notification filed by Orex Computed Radiography Ltd with the FDA for Port Cassette.
| Device ID | K032654 |
| 510k Number | K032654 |
| Device Name: | PORT CASSETTE |
| Classification | System, Imaging, X-ray, Electrostatic |
| Applicant | OREX COMPUTED RADIOGRAPHY LTD 49 PLAIN ST. North Attleboro, MA 02760 |
| Contact | Mary Mcnamara-cullinane |
| Correspondent | Mary Mcnamara-cullinane OREX COMPUTED RADIOGRAPHY LTD 49 PLAIN ST. North Attleboro, MA 02760 |
| Product Code | IXK |
| CFR Regulation Number | 892.1630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-08-28 |
| Decision Date | 2003-10-09 |
| Summary: | summary |