The following data is part of a premarket notification filed by See-mode Technologies Pte. Ltd. with the FDA for Ava (augmented Vascular Analysis).
| Device ID | K201369 |
| 510k Number | K201369 |
| Device Name: | AVA (Augmented Vascular Analysis) |
| Classification | System, Image Processing, Radiological |
| Applicant | See-Mode Technologies Pte. Ltd. 32 Carpenter Street, #03-01 Singapore, SG 059911 |
| Contact | Sadaf Monajemi |
| Correspondent | Alan Donald Matrix Medical Consulting, Inc. 8880 Rio San Diego Drive, Suite 800 San Diego, CA 92108 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-05-22 |
| Decision Date | 2020-09-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860006305703 | K201369 | 000 |