Data / Medical devices / United Kingdom / Simpleware Product Group, SYNOPSYS NORTHERN EUROPE

Simpleware Product Group, SYNOPSYS NORTHERN EUROPE: FDA-registered device maker in Exeter Devon, United Kingdom, 2 510(k) clearances

Name: Simpleware Product Group, SYNOPSYS NORTHERN EUROPE FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Simpleware Product Group, SYNOPSYS NORTHERN EUROPE is registered with the FDA (registration 3011676026) in Exeter Devon, United Kingdom. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated April 1, 2021. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 3, 2026.

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FDA registration number: 3011676026
Address: Bradninch Hall, Castle Street, Exeter Devon, United Kingdom, EX4 3PL
Owner or operator: Synopsys Northern Europe (10049175)
Roles: Complaint file establishment, Manufacturer
First device listed: April 24, 2015
Registered through: 2026
Brand names listed: Simpleware Medical, Simpleware ScanIP Medical

Devices it lists

Device	Product code	Class	Role	Source
System, Image Processing, Radiological	LLZ	2	Complaint file establishment, Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
April 1, 2021	K203195	Simpleware ScanIP Medical	LLZ	Substantially Equivalent	Synopsys (Northern Europe) , Ltd.	accessdata.fda.gov
April 17, 2015	K142779	SCANIP; SCANIP: MEDICAL EDITION; SCANIP: MED	LLZ	Substantially Equivalent	Simpleware , Ltd.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
June 4, 2021	88207	Class II	Terminated	Simpleware ScanIP software. For transfer of imaging information from a medical scanner to an output file, and for simulating/evaluating surgical treatment options.	A issue (bug) has been identified with the interface and image software which could result in anatomical orientation tags/labels being displayed incorrectly. This could result in operator misunderstanding and errors during resampling or re-alignment of image data	accessdata.fda.gov

Compare with other makers

All makers of System, Image Processing, Radiological

Updated April 1, 2021. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.