The following data is part of a premarket notification filed by Aktina Medical Physics Corp. with the FDA for Aktina Medical Physics Corporation Photon Beam Blocking System.
| Device ID | K974239 |
| 510k Number | K974239 |
| Device Name: | AKTINA MEDICAL PHYSICS CORPORATION PHOTON BEAM BLOCKING SYSTEM |
| Classification | Block, Beam-shaping, Radiation Therapy |
| 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 | IXI |
| CFR Regulation Number | 892.5710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-11-12 |
| Decision Date | 1998-02-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B365534260 | K974239 | 000 |
| B365534180 | K974239 | 000 |
| B365112900 | K974239 | 000 |
| B365112850 | K974239 | 000 |