FDA.reportPublic FDA data

MP-1S

Primary DI
B310MP1S0
Brand
MP-1S
Company
NIDEK TECHNOLOGIES SRL
Model
MP-1S
Device description
The MP-1S MICRO PERIMETER is indicated for use as:·Color retinography·Fixation examiner·Fundus-related microperimetry·Visual rehabilitation
Published
2016-08-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HKICamera, Ophthalmic, Ac-Powered
HPTPerimeter, Automatic, Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HKICamera, Ophthalmic, Ac-PoweredOphthalmic2
HPTPerimeter, Automatic, Ac-PoweredOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B310MP1S0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic fundus cameraAn electrically-powered optical device intended to be used to create digital colour photographic images/video of the ocular fundus (interior eye surface opposite the lens) through the pupil, to aid in diagnosing and monitoring retinal pathology; it may also be used for images/video of the anterior chamber. The image/video is typically transferred to a computer for display on its screen and/or for storage in a database. This device is also known as a retinal camera.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
436748037
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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00857253006149Phoenix ICON GO & FA Module with Training Kit Phoenix ClinicalHKI2026-04-03
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05713315011948RetCam EnvisionNatus Medical Denmark ApSHKI2026-02-10
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06430046260689Smartscope Pro retinal setOptomed OyHKI2025-11-13
00860011691761Radius InspireRadiusXR, Inc.HPT2025-09-22
045601262691023D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(Type:Maestro2)TOPCON CORPORATIONHKI2025-09-11
00860014304507OptainOptain Health, Inc.HKI2025-07-07
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03664188000589ZEISSLUNEAU TECHNOLOGY OPERATIONSHKI2025-03-11
G617RVF2001RetinaLogikRetinalogik Inc.HPT2025-03-07
00860000249584Verily Numetric Retinal Camera VERILY LIFE SCIENCES LLCHKI2025-02-24
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