The following data is part of a premarket notification filed by Visionquest Biomedical, Inc. with the FDA for Image Quality Analyzer (iqa).
| Device ID | K200422 |
| 510k Number | K200422 |
| Device Name: | Image Quality Analyzer (IQA) |
| Classification | System, Image Management, Ophthalmic |
| Applicant | VisionQuest BioMedical, Inc. 2501 Yale Blvd SE #301 Albuquerque, NM 87106 |
| Contact | Gilberto Zamora |
| Correspondent | Ryan Bouchard ORA 300 Brickstone Square Andover, MA 01810 |
| Product Code | NFJ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-02-20 |
| Decision Date | 2020-12-24 |