Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3021059265

FEI Number

3021059265

Entity Name

MEDICAL IMAGING SALE AND SERVICE INC

City/State/Country

Farmingdale, NJ, US

Establishment Address

165 Central Avenue, Farmingdale, NJ 07727, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

medical imaging sale and service Inc (Owner Number: 10083567)

Owner / Operator Contact Address

165 Central Avenue, Farmingdale, NJ 07727, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K122286

PMA Number

N/A

All Registered Proprietary Names

Siemens Medical Solutions Philips iCT CT System GE Medical Systems Toshiba AQUILION PRIME GE Healthcare Siemens MAGNETOM Avanto Siemens MAGNETOM Verio GE Healthcare GE Healthcare Siemens Medical Solutions GE Lightspeed VCT 64 CT Scanner Siemens SOMATOM X.cite Siemens SOMATOM go.Open Pro Siemens SOMATOM go.Now Siemens SOMATOM X.ceed Siemens SOMATOM go.Sim Siemens SOMATOM go.All Siemens SOMATOM go.Top Siemens SOMATOM go.Up GE Medical Systems LLC Hologic, Inc. Digital Mammogram Siemens AG/Siemens Healthcare GmnbH Siemens Medical Solutions OPTIMA CT520 Siemens Symbia SPECT and SPECT/CT Systems GE Healthcare Optima CT660 S Pro Optima CT660 Pro J Revolution EVO ES Optima CT660 FREEdom Optima CT 670 Revolution EVO EL CT660 Cj2.5 Upgrade Optima CT680 Professional Revolution EVO EX Optima CT680 Quantum Optima CT660 Pro Optima CT660 Optima CT660s Revolution EVO Optima CT660 SE Optima CT680 Expert DISCOVERY CT750 HD Symbia Siemens Medical Systems

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2025-01-27
LNI	System, Nuclear Magnetic Resonance Spectroscopic	Radiology	Class 2	892.1000	2025-01-27
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2025-01-27
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2026-01-08
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2024-03-29
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2026-01-08
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2025-02-25
KPS	System, Tomography, Computed, Emission	Radiology	Class 2	892.1200	2025-02-25
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2026-01-08
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2026-01-08
LNI	System, Nuclear Magnetic Resonance Spectroscopic	Radiology	Class 2	892.1000	2026-01-08
OXO	Image-Intensified Fluoroscopic X-Ray System, Mobile	Radiology	Class 2	892.1650	2025-02-25
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2025-02-25
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2025-02-25
OXO	Image-Intensified Fluoroscopic X-Ray System, Mobile	Radiology	Class 2	892.1650	2025-07-11
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2025-07-11
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2025-07-11
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2025-02-25
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2025-02-25
IZI	System, X-Ray, Angiographic	Radiology	Class 2	892.1600	2025-02-25
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2025-02-25
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2023-05-22
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2026-01-08
KPS	System, Tomography, Computed, Emission	Radiology	Class 2	892.1200	2025-03-31
MUE	Full Field Digital, System, X-Ray, Mammographic	Radiology	Class 2	892.1715	2026-01-08
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2024-12-16
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2024-10-04
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2026-03-18
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2026-01-08
KPS	System, Tomography, Computed, Emission	Radiology	Class 2	892.1200	2026-01-08
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2025-05-23
KPR	System, X-Ray, Stationary	Radiology	Class 2	892.1680	2025-05-23
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2026-03-13
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2026-03-18
KPS	System, Tomography, Computed, Emission	Radiology	Class 2	892.1200	2026-03-20
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2026-03-20
MUE	Full Field Digital, System, X-Ray, Mammographic	Radiology	Class 2	892.1715	2025-01-21

Official Correspondent

kenan yilmaz

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

medical imaging sale and service 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
K033504	General Electric Co.	GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM	2003-11-25
K013636	GE Medical Systems	SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGY	2002-01-24
K250443	Siemens Healthcare GmbH	MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile	2025-06-16
K151015	Hitachi Medical Systems America, Inc.	ECHELON Oval V 5.0 MRI System	2015-07-29
K910715	Philips Medical Systems (Cleveland), Inc.	VISTA HPQ SYSTEM	1991-06-07

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0029-2007	Hitachi Medical Systems America Inc	2	MRP-7000 and AIRIS Magnetic Resonance Imaging Systems, Software Versions: V7.0A to V7.0J.
Z-0033-2014	Philips Medical Systems (Cleveland) Inc	2	Philips MR Systems: Asset 0.5T, Apollo 0.5T, Infinion 1.5T, Eclipse/Polaris 1.5T, Panorama 0.6T 1.0T, Magnetic Resonance Imaging Systems intended for clinical/radiologic diagnostic imaging applications.
Z-0389-2024	Philips North America Llc	2	Achieva 1.5T
Z-0390-2024	Philips North America Llc	2	Achieva 1.5T Conversion
Z-0391-2024	Philips North America Llc	2	Achieva 1.5T Initial System

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3021059265. Last updated year: 2026. Please use registration number 3021059265 when referencing this establishment in official correspondence.