The following data is part of a premarket notification filed by Atlaim with the FDA for Atal-8.
| Device ID | K113812 |
| 510k Number | K113812 |
| Device Name: | ATAL-8 |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | ATLAIM 81 SEACOUNTRY LANE Rancho Santa Margarita, CA 92688 |
| Contact | Daniel Kamm |
| Correspondent | Daniel Kamm ATLAIM 81 SEACOUNTRY LANE Rancho Santa Margarita, CA 92688 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-23 |
| Decision Date | 2012-05-03 |
| Summary: | summary |