The following data is part of a premarket notification filed by Alara, Inc. with the FDA for Crystalview T-series Computed Radiography System, Models T110 (with Eraser) And T100 (without Eraser).
| Device ID | K071682 |
| 510k Number | K071682 |
| Device Name: | CRYSTALVIEW T-SERIES COMPUTED RADIOGRAPHY SYSTEM, MODELS T110 (WITH ERASER) AND T100 (WITHOUT ERASER) |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | ALARA, INC. 47505 SEABRIDGE DRIVE Fremont, CA 94538 |
| Contact | Robert Lundberg |
| Correspondent | Robert Lundberg ALARA, INC. 47505 SEABRIDGE DRIVE Fremont, CA 94538 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-06-19 |
| Decision Date | 2007-08-15 |
| Summary: | summary |