The following data is part of a premarket notification filed by Aktina Medical Physics Corp. with the FDA for Pinpoint Stereotactic Head And Neck Localizer.
| Device ID | K103616 |
| 510k Number | K103616 |
| Device Name: | PINPOINT STEREOTACTIC HEAD AND NECK LOCALIZER |
| 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 | 2010-12-10 |
| Decision Date | 2011-01-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B365501070 | K103616 | 000 |
| B365508550 | K103616 | 000 |
| B365601100 | K103616 | 000 |
| B365601200 | K103616 | 000 |
| B365601400 | K103616 | 000 |
| B365601500 | K103616 | 000 |
| B365601600 | K103616 | 000 |
| B365601700 | K103616 | 000 |
| B365602200 | K103616 | 000 |
| B365602300 | K103616 | 000 |
| B365605100 | K103616 | 000 |
| B365502650 | K103616 | 000 |
| B365502550 | K103616 | 000 |
| B365501860 | K103616 | 000 |
| B365501170 | K103616 | 000 |
| B365501190 | K103616 | 000 |
| B365501200 | K103616 | 000 |
| B365501260 | K103616 | 000 |
| B365501270 | K103616 | 000 |
| B365501300 | K103616 | 000 |
| B365501380 | K103616 | 000 |
| B365501420 | K103616 | 000 |
| B365501520 | K103616 | 000 |
| B365501530 | K103616 | 000 |
| B365605200 | K103616 | 000 |
| B365605220 | K103616 | 000 |
| B365504551 | K103616 | 000 |
| B365504601 | K103616 | 000 |
| B365504651 | K103616 | 000 |
| B365504701 | K103616 | 000 |
| B365505000 | K103616 | 000 |
| B365505010 | K103616 | 000 |
| B365505100 | K103616 | 000 |
| B365505200 | K103616 | 000 |
| B365507201 | K103616 | 000 |
| B365601000 | K103616 | 000 |
| B365502680 | K103616 | 000 |
| B365501350 | K103616 | 000 |
| B365508400 | K103616 | 000 |
| B365605250 | K103616 | 000 |
| B365605400 | K103616 | 000 |
| B365605430 | K103616 | 000 |
| B365605450 | K103616 | 000 |
| B365605500 | K103616 | 000 |
| B365508070 | K103616 | 000 |
| B365508300 | K103616 | 000 |
| B365508320 | K103616 | 000 |
| B365508050 | K103616 | 000 |
| B365508060 | K103616 | 000 |
| B365805000 | K103616 | 000 |