Data / Medical devices / United States / Aktina Medical Corp.
Aktina Medical Corp.: FDA-registered device maker in Congers, NY, United States, 13 510(k) clearances
Aktina Medical Corp. is registered with the FDA (registration 2436865) in Congers, NY, United States. It lists 7 device types. The FDA files 13 510(k) clearances under its listings, the newest dated September 25, 2019. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 2436865
- FEI number
- 1000521490
- Address
- 360 N Route 9w, Congers, NY, United States, 10920
- Owner or operator
- AKTINA MEDICAL CORP. (9011840)
- Roles
- Manufacturer
- First device listed
- July 22, 2003
- Registered through
- 2026
- Brand names listed
- AKTINA FILMS, Active Breathing Coordinator, Beam Block Tray, Carbon Fiber Table Top, Circular Small Field Collimators, Elekta Integrated, Electron Beam Shaping System, Frontpointer, PINPOINT STEREOTACTIC HEAD AND NECK LOCALIZER (Aktina Mouthpiece) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accelerator, Linear, Medical | IYE | 2 | Manufacturer | accessdata.fda.gov |
| Block, Beam-Shaping, Radiation Therapy | IXI | 2 | Manufacturer | accessdata.fda.gov |
| Couch, Radiation Therapy, Powered | JAI | 2 | Manufacturer | accessdata.fda.gov |
| Film, Radiographic | IWZ | 1 | Manufacturer | accessdata.fda.gov |
| Holder, Radiographic Cassette, Wall-Mounted | IXY | 1 | Manufacturer | accessdata.fda.gov |
| Instrument, Quality-Assurance, Radiologic | LHO | 1 | Manufacturer | accessdata.fda.gov |
| Monitor, Patient Position, Light-Beam | IWE | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 25, 2019 | K192102 | Thermoplastic Masks | IYE | Substantially Equivalent | Aktina Medical Corporation | accessdata.fda.gov |
| September 27, 2016 | K161984 | Interlocked Circular Small Field Collimators, Elekta Integrated | IYE | Substantially Equivalent | Aktina Medical Corporation | accessdata.fda.gov |
| May 15, 2015 | K151097 | Active Breathing Coordinator | IYE | Substantially Equivalent | Aktina Medical Corporation | accessdata.fda.gov |
| January 25, 2011 | K103616 | PINPOINT STEREOTACTIC HEAD AND NECK LOCALIZER | IYE | Substantially Equivalent | Aktina Medical Physics Corp. | accessdata.fda.gov |
| April 28, 2004 | K040709 | PROTOS SOFTWARE | IYE | Substantially Equivalent | Aktina Medical Physics Corp. | accessdata.fda.gov |
| September 25, 2003 | K032248 | PRECISE CARBON FIBER TABLE TOP, MODEL 11-999 | IYE | Substantially Equivalent | Aktina Medical Physics Corp. | accessdata.fda.gov |
| March 5, 2002 | K014081 | AKTINA MEDICAL PHYSICS RADIATION THERAPY WEDGES | IYE | Substantially Equivalent | Aktina Medical Physics Corp. | accessdata.fda.gov |
| January 10, 2000 | K993522 | AKTINA MEDICAL PHYSICS CORPORATION TENNIS RACQUET INSERT | JAI | Substantially Equivalent | Aktina Medical Physics Corp. | accessdata.fda.gov |
| July 30, 1999 | K991546 | AKTINA MEDICAL PHYSICS CORPORATION TILT BOARD | IYE | Substantially Equivalent | Aktina Medical Physics Corp. | accessdata.fda.gov |
| June 22, 1999 | K990997 | AKTINA MEDICALPHYSICS CORPORATION MECHANICAL FRONTPOINTER | IYE | Substantially Equivalent | Aktina Medical Physics Corp. | accessdata.fda.gov |
| February 10, 1998 | K974239 | AKTINA MEDICAL PHYSICS CORPORATION PHOTON BEAM BLOCKING SYSTEM | IXI | Substantially Equivalent | Aktina Medical Physics Corp. | accessdata.fda.gov |
| January 14, 1998 | K973953 | AKTINA MEDICAL PHYSICS CORPORATION EECTRON BEAM FIELD SHAPING SYSTEM | IXI | Substantially Equivalent | Aktina Medical Physics Corp. | accessdata.fda.gov |
| February 11, 1997 | K964840 | BEAM BLOCK TRAYS | IYE | Substantially Equivalent | Aktina Medical Physics Corp. | accessdata.fda.gov |
Compare with other makers
- All makers of Monitor, Patient Position, Light-Beam
- All makers of Accelerator, Linear, Medical
- All makers of Couch, Radiation Therapy, Powered
- All makers of Block, Beam-Shaping, Radiation Therapy
- All makers of Film, Radiographic
- All makers of Holder, Radiographic Cassette, Wall-Mounted
Updated September 25, 2019. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.