The following data is part of a premarket notification filed by Ka Imaging Inc. with the FDA for Flat Panel Detector.
| Device ID | K201591 |
| 510k Number | K201591 |
| Device Name: | Flat Panel Detector |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | KA Imaging Inc. 560 Parkside Dr #3 Waterloo, CA N2l 5z4 |
| Contact | Samuel To |
| Correspondent | Amol Karnick KA Imaging Inc. 560 Parkside Dr #3 Waterloo, CA N2l 5z4 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-12 |
| Decision Date | 2020-09-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 16280119411015 | K201591 | 000 |
| 00628011941015 | K201591 | 000 |