The following data is part of a premarket notification filed by First Source, Inc. with the FDA for I-q View.
| Device ID | K203703 |
| 510k Number | K203703 |
| Device Name: | I-Q View |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | First Source, Inc. 3495 Winton Place, Bldg E Ste 1 Rochester, NY 14623 |
| Contact | Susan Ryan-kron |
| Correspondent | Susan Ryan-kron First Source, Inc. 3495 Winton Place, Bldg E Ste 1 Rochester, NY 14623 |
| Product Code | MQB |
| Subsequent Product Code | IZL |
| Subsequent Product Code | LLZ |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-12-18 |
| Decision Date | 2021-03-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| G221200CA3080 | K203703 | 000 |