Simpleware Product Group, SYNOPSYS NORTHERN EUROPE
Exeter Devon, GB
Simpleware Product Group, SYNOPSYS NORTHERN EUROPE appears in FDA device records in Exeter Devon, GB. FDA records list no 510(k) clearances, no PMA records and one registered establishment. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3011676026 | 3011676026 | Simpleware Product Group, SYNOPSYS NORTHERN EUROPE | Bradninch Hall, Castle Street, Exeter Devon EX4 3PL GB | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2254-2021 | Simpleware ScanIP medical 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 | Class II | Terminated | |
| Z-2253-2021 | 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 | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain