The following data is part of a premarket notification filed by Synopsys (northern Europe) Ltd. with the FDA for Simpleware Scanip Medical.
| Device ID | K203195 |
| 510k Number | K203195 |
| Device Name: | Simpleware ScanIP Medical |
| Classification | System, Image Processing, Radiological |
| Applicant | Synopsys (Northern Europe) Ltd. Bradninch Hall, Castle Street Exeter, GB Ex4 3pl |
| Contact | Jessica James |
| Correspondent | Jessica James Synopsys (Northern Europe) Ltd. Bradninch Hall, Castle Street Exeter, GB Ex4 3pl |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-10-28 |
| Decision Date | 2021-04-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00863520000390 | K203195 | 000 |