FDA.reportPublic FDA data

EpisurfView

Primary DI
EPIS960010
Brand
EpisurfView
Company
Episurf Operations AB
Model
1.0
Published
2026-03-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
EPIS960010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Radiology DICOM image processing application softwareA software application intended to facilitate management, distribution, and/or viewing of radiological digital imaging and communications in medicine (DICOM) image data; it is not intended for pathological image interpretation (i.e., not intended to detect and localize suspected abnormalities). It may be intended to facilitate image management (e.g., viewing, communication, printing, recording/disc burning) and/or image quality manipulation and quantification (e.g., non-interpretive graphical overlays).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
352393402
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
EPIS18100PF0Episealer Knee Revision GuideFirst version18100PF2023-07-24
EPIS31120PF0Femoral ComponentD2031120PF2023-07-24
EPIS31125PF0Femoral ComponentD2531125PF2023-07-24
EPIS31129PF0Femoral ComponentD2931129PF2023-07-24
EPIS32120PF0Femoral EpidrillD2032120PF2023-07-24
EPIS32125PF0Femoral EpidrillD2532125PF2023-07-24
EPIS32129PF0Femoral EpidrillD2932129PF2023-07-24
EPIS33120PF0Femoral Drilling SocketD2033120PF2023-07-24
EPIS33125PF0Femoral Drilling SocketD2533125PF2023-07-24
EPIS33129PF0Femoral Drilling SocketD2933129PF2023-07-24
EPIS33420PF0Femoral Adjustment SocketD2033420PF2023-07-24
EPIS33425PF0Femoral Adjustment SocketD2533425PF2023-07-24
EPIS33429PF0Femoral Adjustment SocketD2933429PF2023-07-24
EPIS33720PF0Femoral EpiguideD2033720PF2023-07-24
EPIS33725PF0Femoral EpiguideD2533725PF2023-07-24
EPIS33729PF0Femoral EpiguideD2933729PF2023-07-24
EPIS34120PF0Femoral EpidummyD2034120PF2023-07-24
EPIS34125PF0Femoral EpidummyD2534125PF2023-07-24
EPIS34129PF0Femoral EpidummyD2934129PF2023-07-24
EPIS37320PF0Femoral EpimandrelD2037320PF2023-07-24

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00818834028837MiiS Horus Endoscope Display System -Video BoxTRI-ANIM HEALTH SERVICES, INC.LMD2025-08-12
08800184000009I-Rapha ViewIRM IncLMD2025-08-01
00612479273580McKessonMCKESSON MEDICAL-SURGICAL INC.LMD2025-07-15