Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2431392

FEI Number

2431392

Entity Name

MICK RADIO-NUCLEAR INSTRUMENTS, INC.

City/State/Country

MOUNT VERNON, NY, US

Establishment Address

521 HOMESTEAD AVE., MOUNT VERNON, NY 10550, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Mick Radio-Nuclear Instruments, Inc. (Owner Number: 10045775)

Owner / Operator Contact Address

521 Homestead Avenue, Mount Vernon, NY 10550, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K993472

PMA Number

N/A

All Registered Proprietary Names

TBI Stand HDR CT Compatible Split Ring Applicator Plastic Split Ring Build Up Caps HDR Tandem Ring Applicator H.A.M Applicator Superflab Perma-Doc Vienna System Graticule Hilaris-Nori Cervix Applicator CT Compatible Intrauterine Sleeves HDR CT Compatible Ring & Tandem Applicator w/ 2 Piece Rectal Retractor Henschke Applicator Mick TP/TPV 200 Applicator System Shielded Vaginal Applicator Wang Applicator Interstitial Implant Accessories Hilaris-Nori Endometrial Applicator IBC HDR CT Compatible F/S/D Applicator Mick Valencia Applicator Set Segmented Vaginal Applicator

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IYE	Accelerator, Linear, Medical	Radiology	Class 2	892.5050	2014-08-28
JAQ	System, Applicator, Radionuclide, Remote-Controlled	Radiology	Class 2	892.5700	2013-12-26
JAQ	System, Applicator, Radionuclide, Remote-Controlled	Radiology	Class 2	892.5700	2014-08-28
JAQ	System, Applicator, Radionuclide, Remote-Controlled	Radiology	Class 2	892.5700	2015-12-22
IYP	Phantom, Anthropomorphic, Nuclear	Radiology	Class 1	892.1370	2015-12-22
IYE	Accelerator, Linear, Medical	Radiology	Class 2	892.5050	2013-12-26
JAQ	System, Applicator, Radionuclide, Remote-Controlled	Radiology	Class 2	892.5700	2016-09-25
IYE	Accelerator, Linear, Medical	Radiology	Class 2	892.5050	2013-12-26
IWJ	System, Applicator, Radionuclide, Manual	Radiology	Class 1	892.5650	2014-08-28
JAQ	System, Applicator, Radionuclide, Remote-Controlled	Radiology	Class 2	892.5700	2014-08-28
JAQ	System, Applicator, Radionuclide, Remote-Controlled	Radiology	Class 2	892.5700	2014-08-28
IWJ	System, Applicator, Radionuclide, Manual	Radiology	Class 1	892.5650	2014-08-28
IWJ	System, Applicator, Radionuclide, Manual	Radiology	Class 1	892.5650	2013-12-26
JAQ	System, Applicator, Radionuclide, Remote-Controlled	Radiology	Class 2	892.5700	2014-08-28
IWJ	System, Applicator, Radionuclide, Manual	Radiology	Class 1	892.5650	2014-08-28
JAQ	System, Applicator, Radionuclide, Remote-Controlled	Radiology	Class 2	892.5700	2014-08-28
IWJ	System, Applicator, Radionuclide, Manual	Radiology	Class 1	892.5650	2014-08-28
IYE	Accelerator, Linear, Medical	Radiology	Class 2	892.5050	2014-08-28
JAQ	System, Applicator, Radionuclide, Remote-Controlled	Radiology	Class 2	892.5700	2014-08-28
JAQ	System, Applicator, Radionuclide, Remote-Controlled	Radiology	Class 2	892.5700	2023-11-14
JAQ	System, Applicator, Radionuclide, Remote-Controlled	Radiology	Class 2	892.5700	2014-08-28

Official Correspondent

Natalia Khramova

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Mick Radio-Nuclear Instruments, Inc.

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
K973037	Avid N.I.T., Inc.	N.I.T., INC. RADIONUCLIDE SEED APPLICATOR, MODEL SA-1000	1998-01-27

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 2431392. Last updated year: 2026. Please use registration number 2431392 when referencing this establishment in official correspondence.