The following data is part of a premarket notification filed by Synaptive Medical Inc. with the FDA for Brightmatter Plan 1.6.0.
| Device ID | K180394 |
| 510k Number | K180394 |
| Device Name: | BrightMatter Plan 1.6.0 |
| Classification | System, Image Processing, Radiological |
| Applicant | Synaptive Medical Inc. 555 Richmond Street West, Suite 800 Toronto, CA M5v 3b1 |
| Contact | Maham Ansari |
| Correspondent | Maham Ansari Synaptive Medical Inc. 555 Richmond Street West, Suite 800 Toronto, CA M5v 3b1 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-02-13 |
| Decision Date | 2018-03-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00670082000443 | K180394 | 000 |
| 00670082000412 | K180394 | 000 |
| 00670082000511 | K180394 | 000 |