FDA.reportPublic FDA data

RetCam Envision

Primary DI
05713315011641
Brand
RetCam Envision
Company
Natus Medical Denmark ApS
Model
RETCAM-FA-UPGRADE
Catalog number
RETCAM-FA-UPGRADE
Device description
FA Upgrade kit for - RetCam Envision without FA
Published
2026-02-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

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
K203500000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203500000RetCam EnvisionNatus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)2021-04-13HKI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05713315011641PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05713315011641057133150116415713315011641

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
306633756
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05713315008474Otometrics1085, FACE CUSHION 2 ASM KIT8-35-501002020-06-02
05713315008443Otometrics1085, STRAP ASSEMBLY8-35-342002019-11-20
05713315008467Otometrics1085, FACE PAD ASSEMBLY KIT V28-35-393002020-05-18
05713315003295OtometricsGoggle face cushion kit2019-04-24
05713315005268GN Otometrics A/S1085, GOGGLE HOME KIT2016-09-23
05713315002915GN Otometrics A/SDisposable Diff VEMP Electrode2019-04-01
05713315002649GN Otometrics A/S"Disposable Electrode 24"" Wired Qty 10"2016-09-26
05713315000874GN Otometrics A/SOTOair Bluetooth Dongle2016-09-19
05713315011597RetCam Envision61-00030061-0003002026-02-10
05713315011924RetCam Envision60-00007060-0000702026-02-10
05713315011931RetCam Envision60-00009060-0000902026-02-10
05713315011948RetCam Envision60-00009260-0000922026-02-10
05713315011962RetCam Envision61-00050061-0005002026-02-10
05713315012068Echo-Screen III0135700135702026-01-29
05713315012013Echo-Screen III0091490091492026-01-28
05713315012037Echo-Screen III0109990109992026-01-28
05713315012051Echo-Screen III0126250126252026-01-28
05713315011436ALGO Pro0361770361772026-01-23
05713315011443ALGO Pro0362440362442026-01-23
05713315011450ALGO Pro0362340362342026-01-23

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
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
20852788008037NeolightNEOLIGHT LLCHKI2025-01-26