The following data is part of a premarket notification filed by Aktina Medical Physics Corp. with the FDA for Aktina Medical Physics Radiation Therapy Wedges.
| Device ID | K014081 |
| 510k Number | K014081 |
| Device Name: | AKTINA MEDICAL PHYSICS RADIATION THERAPY WEDGES |
| Classification | Accelerator, Linear, Medical |
| Applicant | AKTINA MEDICAL PHYSICS CORP. 360 NORTH ROUTE 9W Congers, NY 10920 |
| Contact | Joan Kacharopoulos |
| Correspondent | Joan Kacharopoulos 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 | 2001-12-11 |
| Decision Date | 2002-03-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B36556300MX600 | K014081 | 000 |
| B36556300DX150 | K014081 | 000 |
| B36556300DI600 | K014081 | 000 |
| B36556300DI450 | K014081 | 000 |
| B36556300DI300 | K014081 | 000 |
| B36556300DI150 | K014081 | 000 |
| B36511495600 | K014081 | 000 |
| B36511495450 | K014081 | 000 |
| B36511495300 | K014081 | 000 |
| B36556300DX300 | K014081 | 000 |
| B36556300DX450 | K014081 | 000 |
| B36556300MX450 | K014081 | 000 |
| B36556300MX300 | K014081 | 000 |
| B36556300MX150 | K014081 | 000 |
| B36556300MI600 | K014081 | 000 |
| B36556300MI450 | K014081 | 000 |
| B36556300MI300 | K014081 | 000 |
| B36556300MI150 | K014081 | 000 |
| B36556300DX600 | K014081 | 000 |
| B36511495150 | K014081 | 000 |