FDA.reportPublic FDA data

RetCam Portable

Primary DI
00864222000428
Brand
RetCam Portable
Company
NATUS MEDICAL INC
Model
RetCam Portable
Device description
The RetCam Portable Ophthalmic Imaging System is designed to allow the quick and easy capture of wide field, high resolution, fully digital images and videos of the eye.
Published
2017-12-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HKICamera, Ophthalmic, Ac-PoweredOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K090326000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K090326000RET CAM II, RETCAM 3 AND RETCAM SHUTTLE AND PORTABLE OPHTHALMIC IMAGING SYSTEMSClarity Medical Systems2009-11-25HKI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00899281002137PreviousGS10
00864222000428PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00899281002137008992810021378992810021370899281002137
00864222000428008642220004288642220004280864222000428

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure20.7 Inches of Mercury31.3 Inches of Mercury
Handling Environment Humidity30 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature59 Degrees Fahrenheit95 Degrees Fahrenheit
Storage Environment Atmospheric Pressure20.7 Inches of Mercury31.3 Inches of Mercury
Storage Environment Humidity30 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature14 Degrees Fahrenheit131 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
+1 650-802-0400service@retcam.com

Regulatory Flags#

DUNS number
080517260
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00864222000404RetCam 3RetCam 32017-12-04
00864222000411RetCam ShuttleRetCam Shuttle2017-12-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10857253006085Phoenix ICON GO Control BoxPhoenix ClinicalHKI2026-05-14
00857253006019ICON HandpiecePhoenix ClinicalHKI2026-04-03
00857253006033FA ModulePhoenix ClinicalHKI2026-04-03
00857253006071DiffuserPhoenix ClinicalHKI2026-04-03
00857253006101Phoenix ICON with Training KitPhoenix ClinicalHKI2026-04-03
00857253006118Phoenix ICON & FA Module with Training KitPhoenix ClinicalHKI2026-04-03
00857253006132Phoenix ICON GO with Training KitPhoenix ClinicalHKI2026-04-03
00857253006149Phoenix ICON GO & FA Module with Training Kit Phoenix ClinicalHKI2026-04-03
05713315011597RetCam EnvisionNatus Medical Denmark ApSHKI2026-02-10
05713315011641RetCam EnvisionNatus Medical Denmark ApSHKI2026-02-10
05713315011924RetCam EnvisionNatus Medical Denmark ApSHKI2026-02-10
05713315011931RetCam EnvisionNatus Medical Denmark ApSHKI2026-02-10
05713315011948RetCam EnvisionNatus Medical Denmark ApSHKI2026-02-10
05713315011962RetCam EnvisionNatus Medical Denmark ApSHKI2026-02-10
06430046261006Optomed Smartscope FAOptomed OyHKI2025-12-12
06430046260597Smartscope Pro full setOptomed OyHKI2025-11-13
06430046260689Smartscope Pro retinal setOptomed OyHKI2025-11-13
045601262691023D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(Type:Maestro2)TOPCON CORPORATIONHKI2025-09-11
00860014304507OptainOptain Health, Inc.HKI2025-07-07
00860010658109Fundus PhotoFundus PhotoHKI2025-03-31
03664188000589ZEISSLUNEAU TECHNOLOGY OPERATIONSHKI2025-03-11
00860000249584Verily Numetric Retinal Camera VERILY LIFE SCIENCES LLCHKI2025-02-24
00852788008019NeolightNEOLIGHT LLCHKI2025-01-26
00852788008026NeolightNEOLIGHT LLCHKI2025-01-26
00852788008040NeolightNEOLIGHT LLCHKI2025-01-26
00852788008057NeolightNEOLIGHT LLCHKI2025-01-26
00852788008064NeolightNEOLIGHT LLCHKI2025-01-26
00852788008071NeolightNEOLIGHT LLCHKI2025-01-26
10852788008085NeolightNEOLIGHT LLCHKI2025-01-26
20852788008020NeolightNEOLIGHT LLCHKI2025-01-26