The following data is part of a premarket notification filed by Qfix with the FDA for Kvue Encompass Srs Insert (encompass Insert), Encompass Srs Standalone (encompass Device), Encompass Srs Mri Immobilization Device (encompass Mri Device, Encompass Intracranial Fibreplast Variable Perf Head Only Open View System, Encompass Intracrani.
| Device ID | K152321 |
| 510k Number | K152321 |
| Device Name: | KVue Encompass SRS Insert (Encompass Insert), Encompass SRS Standalone (Encompass Device), Encompass SRS MRI Immobilization Device (Encompass MRI Device, Encompass Intracranial Fibreplast Variable Perf Head Only Open View System, Encompass Intracrani |
| Classification | Accelerator, Linear, Medical |
| Applicant | QFIX 440 CHURCH ROAD Avondale, PA 19311 |
| Contact | Nadia Sookdeo Harhen |
| Correspondent | Nadia Sookdeo Harhen QFIX 440 CHURCH ROAD Avondale, PA 19311 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-17 |
| Decision Date | 2015-12-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30841962140288 | K152321 | 000 |
| 30841962140271 | K152321 | 000 |
| 10841962118726 | K152321 | 000 |