The following data is part of a premarket notification filed by Object Research Systems (ors) Inc. with the FDA for Vessel Analysis And Autoplaque For Ors Visual.
| Device ID | K122429 |
| 510k Number | K122429 |
| Device Name: | VESSEL ANALYSIS AND AUTOPLAQUE FOR ORS VISUAL |
| Classification | System, Image Processing, Radiological |
| Applicant | OBJECT RESEARCH SYSTEMS (ORS) INC. 760 St-Paul West suite 101 Montreal, CA H3c1m4 |
| Contact | Eric F Ournier |
| Correspondent | Jeff D Rongero UNDERWRITERS LABORATORIES, INC. 12 LABORATORY DR. Research Triangle, NC 27709 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2012-08-09 |
| Decision Date | 2012-11-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B332VIVA0100 | K122429 | 000 |
| B332VIAP0100 | K122429 | 000 |