The following data is part of a premarket notification filed by Aktina Medical Physics Corp. with the FDA for Stereotactic Head And Neck Localizer, Model 50-100.
| Device ID | K081935 |
| 510k Number | K081935 |
| Device Name: | STEREOTACTIC HEAD AND NECK LOCALIZER, MODEL 50-100 |
| Classification | Accelerator, Linear, Medical |
| Applicant | AKTINA MEDICAL PHYSICS CORP. 360 NORTH ROUTE 9W Congers, NY 10920 |
| Contact | Tony Spaccarotella |
| Correspondent | Tony Spaccarotella 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 | 2008-07-07 |
| Decision Date | 2008-10-07 |
| Summary: | summary |