The following data is part of a premarket notification filed by Qfix with the FDA for Encompass Srs Headframe ; Encompass Mr Srs Headframe.
| Device ID | K182189 |
| 510k Number | K182189 |
| Device Name: | Encompass SRS Headframe ; Encompass MR SRS Headframe |
| Classification | Accelerator, Linear, Medical |
| Applicant | Qfix 440 Church Road Avondale, PA 19311 |
| Contact | Alexandra Low Smythe |
| Correspondent | Alexandra Low Smythe Qfix 440 Church Road Avondale, PA 19311 |
| Product Code | IYE |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-13 |
| Decision Date | 2018-10-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10841962110768 | K182189 | 000 |
| 10841962110775 | K182189 | 000 |