The following data is part of a premarket notification filed by Alara, Inc. with the FDA for Crystalview R200.
| Device ID | K062390 |
| 510k Number | K062390 |
| Device Name: | CRYSTALVIEW R200 |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | ALARA, INC. 47505 SEABRIDGE DRIVE Fremont, CA 94538 |
| Contact | Diane M King |
| Correspondent | Diane M King ALARA, INC. 47505 SEABRIDGE DRIVE Fremont, CA 94538 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-16 |
| Decision Date | 2006-09-18 |
| Summary: | summary |