The following data is part of a premarket notification filed by Simpleware Ltd. with the FDA for Scanip; Scanip: Medical Edition; Scanip: Med.
Device ID | K142779 |
510k Number | K142779 |
Device Name: | SCANIP; SCANIP: MEDICAL EDITION; SCANIP: MED |
Classification | System, Image Processing, Radiological |
Applicant | SIMPLEWARE LTD. BRADNINCH HALL, CASTLE STREET Exeter, GB Ex43pl |
Contact | Gareth James |
Correspondent | Gareth James SIMPLEWARE LTD. BRADNINCH HALL, CASTLE STREET Exeter, GB Ex43pl |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-09-26 |
Decision Date | 2015-04-17 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00863520000338 | K142779 | 000 |
00863520000321 | K142779 | 000 |
00863520000314 | K142779 | 000 |
00863520000307 | K142779 | 000 |
00863520000345 | K142779 | 000 |
00863520000376 | K142779 | 000 |
00863520000383 | K142779 | 000 |
00863520000369 | K142779 | 000 |
00863520000352 | K142779 | 000 |