SCANIP; SCANIP: MEDICAL EDITION; SCANIP: MED

System, Image Processing, Radiological

SIMPLEWARE LTD.

The following data is part of a premarket notification filed by Simpleware Ltd. with the FDA for Scanip; Scanip: Medical Edition; Scanip: Med.

Pre-market Notification Details

Device IDK142779
510k NumberK142779
Device Name:SCANIP; SCANIP: MEDICAL EDITION; SCANIP: MED
ClassificationSystem, Image Processing, Radiological
Applicant SIMPLEWARE LTD. BRADNINCH HALL, CASTLE STREET Exeter,  GB Ex43pl
ContactGareth James
CorrespondentGareth James
SIMPLEWARE LTD. BRADNINCH HALL, CASTLE STREET Exeter,  GB Ex43pl
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-09-26
Decision Date2015-04-17
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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

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