The following data is part of a premarket notification filed by Qfix with the FDA for Symphony Patient Transport System, Symphony Patient Trolley, Symphony Standard Transfer Surface, Symphony Portrait (head/neck) Transfer Surface, Symphony Brachytherapy Solution.
| Device ID | K160627 |
| 510k Number | K160627 |
| Device Name: | Symphony Patient Transport System, Symphony Patient Trolley, Symphony Standard Transfer Surface, Symphony Portrait (Head/Neck) Transfer Surface, Symphony Brachytherapy Solution |
| 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 |
| Subsequent Product Code | FRZ |
| Subsequent Product Code | JAI |
| Subsequent Product Code | JAK |
| Subsequent Product Code | KPS |
| Subsequent Product Code | LHN |
| Subsequent Product Code | LNH |
| Subsequent Product Code | OUO |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-03-07 |
| Decision Date | 2016-06-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10841962111277 | K160627 | 000 |
| 10841962119440 | K160627 | 000 |
| 10841962119402 | K160627 | 000 |
| 10841962119419 | K160627 | 000 |
| 10841962119426 | K160627 | 000 |
| 10841962111239 | K160627 | 000 |
| 10841962111246 | K160627 | 000 |
| 10841962111253 | K160627 | 000 |
| 10841962111260 | K160627 | 000 |
| 10841962119433 | K160627 | 000 |