FDA.reportPublic FDA data

MVR

Primary DI
00859151005309
Brand
MVR
Company
MEDICAPTURE, INC.
Model
MVR436
Catalog number
MVR436
Device description
Medical Video Recorder
Published
2025-01-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
LMDSystem, Digital Image Communications, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LMDSystem, Digital Image Communications, RadiologicalRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00859151005309PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00859151005309008591510053098591510053090859151005309

GMDN Terms#

Term, Definition table
TermDefinition
Medical video image recorderAn electrically-powered device designed to be used in conjunction with video endoscopes, radiological equipment, and/or surgical video imaging devices (e.g., surgical microscope, camera) to digitally record video images for subsequent playback; it is not intended for distribution/routing of image data within a network (i.e., not a medical image management system). It is typically a portable device that may incorporate a small screen intended only to reference image capture.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
788868904
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00859151005071MVRMVR460MVR4602025-01-28
00859151005095MTRMTR133MTR1332025-01-28
00859151005118MTRMTR156MTR1562025-01-28
00859151005293MSPMSP156MSP1562025-01-28
00859151005064MVRMVR435MVR4352025-01-27
00859151005088MVRMVR450MVR4502025-01-27
00859151005002MediCapUSB2002020-02-12
00859151005026MediCapUSB1702020-02-12
00859151005033MVRMVR4002020-02-12
00859151005019MediCapUSB3002020-02-12
00859151005101MVRMVR4092020-02-12
00859151005132MVRMVR4202020-02-12
00859151005170MVRMVR4082020-02-12
00859151005255MediCapMVR400Z2020-02-12
00859151005057MTSMTS156MTS1562023-08-31
00859151005286MTSMTS101MTS1012023-02-21
00859151005156MVCMVC4102020-02-12
10859151005009MediCapUSB2002020-02-12
10859151005023MediCapUSB1702020-02-12
20859151005037MVRMVR4002020-02-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
30009336010630Nissha Medical TechnologiesGRAPHIC CONTROLS ACQUISITION CORPLMD2026-06-01
00850025268424Vitrea Advanced Visualization Canon Medical Informatics, Inc.LMD2026-05-12
08800026700890Medit AuraVueMedit Corp.LMD2026-05-11
00810111225663X-ray AppTreace Medical Concepts, Inc.LMD2026-05-01
00628105001212Vitrea ReadCanon Medical Informatics A/SLMD2026-04-27
05415334057258Eonis 32”Barco NVLMD2026-04-13
00628105001229Vitrea ReadCanon Medical Informatics A/SLMD2026-04-03
EPIS960010EpisurfViewEpisurf Operations ABLMD2026-03-17
07290018052402aiOSAIDOC MEDICAL LTDLMD2026-03-08
00850025268400Vitrea Advanced Visualization Canon Medical Informatics, Inc.LMD2026-02-27
04260483290312MammoScapeMeVis Medical Solutions AGLMD2026-02-16
00884838074798IntelliSpace PACS AnywherePhilips Medical Systems Nederland B.V.LMD2026-02-07
00850025268394Vitrea Advanced Visualization Canon Medical Informatics, Inc.LMD2026-01-21
05060634690072EchoGoULTROMICS LIMITEDLMD2026-01-14
00850054590152interWORKSAvreo IncLMD2025-12-08
05415334053045Eonis 3DBarco NVLMD2025-12-01
00628105001205Vitrea ReadCanon Medical Informatics A/SLMD2025-11-21
00850013331086SentiARSentiar, Inc.LMD2025-11-21
00850013331093SentiARSentiar, Inc.LMD2025-11-21
00850013331109SentiARSentiar, Inc.LMD2025-11-21
00850061871374IMAGE DIAGNOSTICS INCIMAGE DIAGNOSTICS, INC.LMD2025-11-18
00850054590145interWORKSAvreo IncLMD2025-11-14
00850025268387Vitrea Advanced Visualization Canon Medical Informatics, Inc.LMD2025-11-03
00850025268370Vitrea Advanced Visualization Canon Medical Informatics, Inc.LMD2025-09-24
00857534006868IMRISmatrix 5.0IMRIS Imaging, Inc.LMD2025-09-18
00857534006875IMRISmatrix 5.0IMRIS Imaging, Inc.LMD2025-09-18
03770024341072Sonio Pro v3SONIOLMD2025-08-28
00850054590138interWORKSAvreo IncLMD2025-08-26
00628105001199Vitrea ReadCanon Medical Informatics A/SLMD2025-08-15
00818834028837MiiS Horus Endoscope Display System -Video BoxTRI-ANIM HEALTH SERVICES, INC.LMD2025-08-12