The following data is part of a premarket notification filed by Aktina Medical Corporation with the FDA for Interlocked Circular Small Field Collimators, Elekta Integrated.
| Device ID | K161984 |
| 510k Number | K161984 |
| Device Name: | Interlocked Circular Small Field Collimators, Elekta Integrated |
| Classification | Accelerator, Linear, Medical |
| Applicant | AKTINA MEDICAL CORPORATION 360 NORTH ROUTE 9W Congers, NY 10920 |
| Contact | Tony Spaccarotella |
| Correspondent | Tony Spaccarotella AKTINA MEDICAL CORPORATION 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 | 2016-07-19 |
| Decision Date | 2016-09-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
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