The following data is part of a premarket notification filed by Object Research Systems, Inc. with the FDA for Ors Visual.
| Device ID | K100335 |
| 510k Number | K100335 |
| Device Name: | ORS VISUAL |
| Classification | System, Image Processing, Radiological |
| Applicant | OBJECT RESEARCH SYSTEMS, INC. 760 ST-PAUL WEST SUITE 101 Montreal, Quebec, CA H3c 1m4 |
| Contact | Eric Fournier |
| Correspondent | John Howlett BSI HEALTHCARE KITEMARK COURT, DAVY AVENUE KNOWLHILL Milton Keynes, GB Mk5 8pp |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2010-02-05 |
| Decision Date | 2010-04-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B332VISU0105 | K100335 | 000 |