The following data is part of a premarket notification filed by Aktina Medical Physics Corp. with the FDA for Beam Block Trays.
| Device ID | K964840 |
| 510k Number | K964840 |
| Device Name: | BEAM BLOCK TRAYS |
| 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 | 1996-11-29 |
| Decision Date | 1997-02-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B365579050 | K964840 | 000 |
| B365115751 | K964840 | 000 |
| B365115741 | K964840 | 000 |
| B365115731 | K964840 | 000 |
| B365115720 | K964840 | 000 |
| B365115710 | K964840 | 000 |
| B365115700 | K964840 | 000 |
| B365115651 | K964840 | 000 |
| B365115631 | K964840 | 000 |
| B365115620 | K964840 | 000 |
| B365115610 | K964840 | 000 |
| B365115600 | K964840 | 000 |
| B365115531 | K964840 | 000 |
| B365115521 | K964840 | 000 |
| B365115511 | K964840 | 000 |
| B365115461 | K964840 | 000 |
| B365113010 | K964840 | 000 |
| B365115761 | K964840 | 000 |
| B365115771 | K964840 | 000 |
| B365579010 | K964840 | 000 |
| B36556000SL0 | K964840 | 000 |
| B36556000HL0 | K964840 | 000 |
| B36556000HA0 | K964840 | 000 |
| B36555000SL0 | K964840 | 000 |
| B36555000HL0 | K964840 | 000 |
| B36554000SL0 | K964840 | 000 |
| B36554000HL0 | K964840 | 000 |
| B365531700 | K964840 | 000 |
| B365531690 | K964840 | 000 |
| B365531680 | K964840 | 000 |
| B36552600SL0 | K964840 | 000 |
| B36552600HL0 | K964840 | 000 |
| B365503600 | K964840 | 000 |
| B365116000 | K964840 | 000 |
| B365115781 | K964840 | 000 |
| B365113000 | K964840 | 000 |