The following data is part of a premarket notification filed by Aktina Medical Physics Corp. with the FDA for Aktina Medical Physics Corporation Tilt Board.
| Device ID | K991546 |
| 510k Number | K991546 |
| Device Name: | AKTINA MEDICAL PHYSICS CORPORATION TILT BOARD |
| Classification | Accelerator, Linear, Medical |
| Applicant | AKTINA MEDICAL PHYSICS CORP. 360 NORTH ROUTE 9W Congers, NY 10920 |
| Contact | Joan Zacharopoulos |
| Correspondent | Joan Zacharopoulos AKTINA MEDICAL PHYSICS CORP. 360 NORTH ROUTE 9W Congers, NY 10920 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-05-03 |
| Decision Date | 1999-07-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B365702000 | K991546 | 000 |
| B365538970 | K991546 | 000 |
| B365538020 | K991546 | 000 |
| B365526340 | K991546 | 000 |
| B365114500 | K991546 | 000 |
| B365114350 | K991546 | 000 |
| B365113800 | K991546 | 000 |
| B365113300 | K991546 | 000 |
| B365113250 | K991546 | 000 |
| B365112330 | K991546 | 000 |
| B365112300 | K991546 | 000 |
| B365542260 | K991546 | 000 |
| B365560530 | K991546 | 000 |
| B365605800 | K991546 | 000 |
| B365605600 | K991546 | 000 |
| B365605000 | K991546 | 000 |
| B365602800 | K991546 | 000 |
| B36511231S0 | K991546 | 000 |
| B365112310 | K991546 | 000 |
| B365112290 | K991546 | 000 |
| B365608120 | K991546 | 000 |
| B365701000 | K991546 | 000 |
| B365561100 | K991546 | 000 |
| B365112250 | K991546 | 000 |