The following data is part of a premarket notification filed by Convergent Imaging Solutions with the FDA for Unisyn Image Fusion, Version 1.0.
| Device ID | K081987 |
| 510k Number | K081987 |
| Device Name: | UNISYN IMAGE FUSION, VERSION 1.0 |
| Classification | System, Image Processing, Radiological |
| Applicant | CONVERGENT IMAGING SOLUTIONS 49 FIRST AVE. SUITE B Ottawa, Ontario, CA K1s 2g1 |
| Contact | Mathew A Thomas |
| Correspondent | Mathew A Thomas CONVERGENT IMAGING SOLUTIONS 49 FIRST AVE. SUITE B Ottawa, Ontario, CA K1s 2g1 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-07-14 |
| Decision Date | 2008-09-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B843UNISYN431P10 | K081987 | 000 |
| B843UNISYN7310 | K081987 | 000 |
| B843UNISYN6250 | K081987 | 000 |
| B843UNISYN7210 | K081987 | 000 |
| B843UNISYN7110 | K081987 | 000 |
| B843UNISYN6240 | K081987 | 000 |
| B843UNISYN6210 | K081987 | 000 |
| B843UNISYN6110 | K081987 | 000 |
| B843UNISYN5610 | K081987 | 000 |
| B843UNISYN5520 | K081987 | 000 |
| B843UNISYN5510 | K081987 | 000 |
| B843UNISYN425P20 | K081987 | 000 |
| B843UNISYN7320 | K081987 | 000 |