The following data is part of a premarket notification filed by Synaptive Medical Inc. with the FDA for Synaptive Imagedrive Pro.
| Device ID | K153284 |
| 510k Number | K153284 |
| Device Name: | Synaptive ImageDrive Pro |
| Classification | System, Image Processing, Radiological |
| Applicant | SYNAPTIVE MEDICAL INC. MARS CENTER, SOUTH TOWER, 101 COLLEGE STREET, SUITE 200 Toronto, CA M5g1l7 |
| Contact | Cameron Piron |
| Correspondent | Cameron Piron SYNAPTIVE MEDICAL INC. MARS CENTER, SOUTH TOWER, 101 COLLEGE STREET, SUITE 200 Toronto, CA M5g1l7 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-12 |
| Decision Date | 2016-03-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00670082000122 | K153284 | 000 |
| 00670082000115 | K153284 | 000 |