The following data is part of a premarket notification filed by Alara, Inc. with the FDA for Alara Crystalview Computed Radiography System.
| Device ID | K032210 |
| 510k Number | K032210 |
| Device Name: | ALARA CRYSTALVIEW COMPUTED RADIOGRAPHY SYSTEM |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | ALARA, INC. 2545 BARRINGTON CT. Hayward, CA 94545 -1134 |
| Contact | Diane M King |
| Correspondent | Diane M King ALARA, INC. 2545 BARRINGTON CT. Hayward, CA 94545 -1134 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-07-21 |
| Decision Date | 2003-10-02 |
| Summary: | summary |