Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009649442

FEI Number

3009649442

Entity Name

CIRTRONICS CORPORATION

City/State/Country

Milford, NH, US

Establishment Address

528 ROUTE 13 S, Milford, NH 03055, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Cirtronics Corporation (Owner Number: 10050924)

Owner / Operator Contact Address

528 Rt 13 South, Milford, NH 03055, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

G-Trainer Ellacor System BeamSite EVox System Lumicell direct Visualization System (DVS)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BXB	Exerciser, Powered	Physical Medicine	Class 1	890.5380	2024-11-19
QAI	Powered Microneedle Device	General, Plastic Surgery	Class 2	878.4430	2021-09-02
IYE	Accelerator, Linear, Medical	Radiology	Class 2	892.5050	2024-01-03
GWJ	Stimulator, Auditory, Evoked Response	Neurology	Class 2	882.1900	2021-06-21
GWQ	Full-Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2021-06-21
SAW	Fluorescence Imaging For Breast Cancer Detection	Unknown	Class 3	N/A	2024-11-19

Official Correspondent

Theodore Trask

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Cirtronics Corporation

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
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 3009649442. Last updated year: 2026. Please use registration number 3009649442 when referencing this establishment in official correspondence.