AKTINA MEDICAL CORP.

FDA Device Registration & Listing · Congers, NY, US · Registration 2436865

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
2436865
FEI Number
1000521490
Entity Name
AKTINA MEDICAL CORP.
City/State/Country
Congers, NY, US
Establishment Address
360 N Route 9w, Congers, NY 10920, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
AKTINA MEDICAL CORP. (Owner Number: 9011840)
Owner / Operator Contact Address
360 NORTH ROUTE 9W, --, Congers, NY 10920, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K014081
PMA Number
N/A

All Registered Proprietary Names

Photon Beam Shaping Block RETICLES AND GRATICULES Tennis Racquet Insert Tilt Board Electron Beam Shaping System Thermoplastic Mask Carbon Fiber Table Top PINPOINT STEREOTACTIC HEAD AND NECK LOCALIZER (Aktina Mouthpiece) AKTINA FILMS Radiation Therapy Wedges

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
IXI Block, Beam-Shaping, Radiation Therapy Radiology Class 2 892.5710 2007-11-06
IWE Monitor, Patient Position, Light-Beam Radiology Class 1 892.5780 2003-07-22
JAI Couch, Radiation Therapy, Powered Radiology Class 2 892.5770 2007-11-06
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2007-11-06
IXI Block, Beam-Shaping, Radiation Therapy Radiology Class 2 892.5710 2007-11-06
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2019-10-08
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2007-11-06
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2016-09-28
IWZ Film, Radiographic Radiology Class 1 892.1840 2004-09-08
LHO Instrument, Quality-Assurance, Radiologic Radiology Class 1 892.1940 2024-02-02
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2007-11-06

Official Correspondent

TONY SPACCAROTELLA

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

AKTINA MEDICAL CORP.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K033316 Brainlab AG TABLE TILT DEVICE 2004-05-14
K071992 Varian Medical Systems HIGH-DEFINITION 120 MULTILEAF COLLIMATOR (HD120 MLC) 2007-08-15
K253962 Radformation, Inc. ClearCheck (RADCC V2.7) 2026-04-03
K003779 Arplay Medical S.A. IMMOBILIZATION SYSTEM FOR ENT 2001-07-12

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0004-2019 Varian Medical Systems 2
TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
Z-0005-2019 Varian Medical Systems 2
VitalBeam Radiotherapy Delivery System Version 2.5 Product Usage: The VitalBeam delivery systems are intended to provide precision radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
Z-0020-2015 N/A 2
Proteus 235 Proton Therapy System for cancer treatment.
Z-0035-2012 Accuray Incorporated 2
CyberKnife Robotic Radiosurgery System, Synchrony Respiratory Tracking System (Standard Treatment Couch). Synchrony Respiratory Tracking System, a Radiation Therapy Device, Model Numbers: 026429, 028185. Product is manufactured and distributed by Accuray, Inc., Sunnyvale, CA
Z-0036-2012 Accuray Incorporated 2
CyberKnife Robotic Radiosurgery System, Synchrony Respiratory Tracking System (Robocouch Patient Positioning System), a Radiation Therapy Device. Model Numbers: 026430, 028186. Product is manufactured and distributed by Accuray, Inc., Sunnyvale, CA

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2436865. Last updated year: 2026. Please use registration number 2436865 when referencing this establishment in official correspondence.
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