The following data is part of a premarket notification filed by Atlaim Corporation with the FDA for Atal 9.
| Device ID | K152151 |
| 510k Number | K152151 |
| Device Name: | ATAL 9 |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | ATLAIM CORPORATION 5F, SMARTBAY. 123, BEOLMAL-RO, DONGAN-GU Anyang-si, KR 431-804 |
| Contact | John Ross |
| Correspondent | Daniel Kamm KAMM & ASSOCIATES 8870 RAVELLO CT Naples, FL 34114 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-03 |
| Decision Date | 2015-11-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809378240061 | K152151 | 000 |
| 08809378240054 | K152151 | 000 |
| 08809378240047 | K152151 | 000 |
| 08809378240030 | K152151 | 000 |
| 08809378240023 | K152151 | 000 |