FDA.reportPublic FDA data

RetCam 3

Primary DI
00864222000404
Brand
RetCam 3
Company
NATUS MEDICAL INC
Model
RetCam 3
Device description
RetCam 3 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
K102859000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K102859000RETCAM 3 OPTHALMIC IMAGING SYSTEMClarity Medical Systems2011-04-20HKI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00899281002113PreviousGS10
00864222000404PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00899281002113008992810021138992810021130899281002113
00864222000404008642220004048642220004040864222000404

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 Temperature50 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
00864222000411RetCam ShuttleRetCam Shuttle2017-12-04
00864222000428RetCam PortableRetCam Portable2017-12-04

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