The following data is part of a premarket notification filed by Aktina Medical Physics Corp. with the FDA for Aktina Medical Physics Corporation Eectron Beam Field Shaping System.
| Device ID | K973953 |
| 510k Number | K973953 |
| Device Name: | AKTINA MEDICAL PHYSICS CORPORATION EECTRON BEAM FIELD SHAPING 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 | 1997-10-16 |
| Decision Date | 1998-01-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B365526260 | K973953 | 000 |
| B365112690 | K973953 | 000 |
| B365530460 | K973953 | 000 |
| B36511268010 | K973953 | 000 |
| B36511268020 | K973953 | 000 |
| B36511268030 | K973953 | 000 |
| B36511268040 | K973953 | 000 |
| B36511268050 | K973953 | 000 |
| B36511269010 | K973953 | 000 |
| B36511269020 | K973953 | 000 |
| B365112700 | K973953 | 000 |
| B365524850 | K973953 | 000 |
| B365112680 | K973953 | 000 |