FDA.reportPublic FDA data

RTVue XR Avanti

Primary DI
00858848006674
Brand
RTVue XR Avanti
Company
OPTOVUE, INC.
Model
100
Catalog number
700-51134-004
Device description
Ophthalmic Optical Coherence Tomography System with 100/240V Table
Published
2019-06-12
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
HLIOphthalmoscope, Ac-Powered
OBOTomography, Optical Coherence

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HLIOphthalmoscope, Ac-PoweredOphthalmic2
OBOTomography, Optical CoherenceOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K153080000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K153080000RTVue XR OCT Avanti with AngioVue SoftwareOptovue, Inc.2016-02-11HLI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00858848006674PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858848006674008588480066748588480066740858848006674

GMDN Terms#

Term, Definition table
TermDefinition
Spectral-domain optical coherence tomography systemA mobile assembly of devices designed to use near infrared (NIR) LED light aimed into the eye to acquire, process, display and save in vivo depth-resolved images of anterior and posterior ocular tissue microstructures in clinical and perioperative examination through the use of interchangeable lenses. Spectral domain optical coherence tomography (SDOCT) is intended to aid in the diagnosis and evaluation of physiologic and pathologic conditions of the eye through non-contact optical imaging. Reflected light is picked up by a detector that converts it into electrical signals using a computer and dedicated software, providing cross-sectional or three-dimensional (3-D) volume scans for analysis.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
866-941-9240service@optovue.com

Regulatory Flags#

DUNS number
196500461
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00858848006285iStandiStand700-48491-0012016-08-03
00858848006759iVueiVue 100700-54520-0012020-08-24
00858848006766iFusioniFusion700-54542-0012020-08-24
00858848006773iVueiVue 100700-54543-0012020-08-24
00858848006780iCamiCam100700-54524-0012020-08-24
00858848006735iScaniVue 500700-52800-0022020-02-13
00858848006742iScaniVue 500700-52801-0022020-02-13
00858848006728RTVue XR Avanti100700-54345-0012020-02-03
00858848006704RTVue XR Avanti100700-51134-0052019-09-20
00858848006667RTVue XR Avanti ScannerAvanti Scanner500-50845-0032019-06-12
00858848006001AvantiRTVue XR100-1700-48076-0042016-08-31
00858848006018iScaniVue 500700-49428-0032016-08-31
00858848006025AvantiRTVue XR100-2700-48098-0042016-08-31
00858848006032AvantiRTVue XR Scanner500-47760-0052016-08-31
00858848006049iVueiVue 100-1700-47817-0042016-08-31
00858848006056iVueiVue 100-1700-47818-0042016-08-31
00858848006063iVueiVue 100700-47826-0052016-08-31
00858848006070iVueiVue 100700-47827-0052016-08-31
00858848006087iVueiVue 100700-48355-0052016-08-31
00858848006094iVueiVue 100-2700-48577-0042016-08-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06945095544135zumaxZumax Medical Co., LTDHLI2026-05-20
06945095544197zumaxZumax Medical Co., LTDHLI2026-05-20
06945095544500zumaxZumax Medical Co., LTDHLI2026-05-20
06942576062461RobotrakRobotrak Technologies Co., LtdHLI2026-04-30
04049584034953Pentacam Cornea OCTOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungOBO2026-03-31
045601262691023D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(Type:Maestro2)TOPCON CORPORATIONOBO2025-09-11
00697077003081Amico Diagnostic StationAmico Diagnostic IncorporatedHLI2025-07-14
04549292147216CANON INC.CANON INC.HLI2025-05-02
04059237000235SPECTRALISHeidelberg Engineering GmbHOBO2025-03-24
04059237000952ANTERIONHeidelberg Engineering GmbHOBO2025-02-05
04059237000723SPECTRALISHeidelberg Engineering GmbHOBO2024-10-04
04059237000792SPECTRALISHeidelberg Engineering GmbHOBO2024-10-04
04059237001027SPECTRALISHeidelberg Engineering GmbHOBO2024-10-04
04059237001034SPECTRALISHeidelberg Engineering GmbHOBO2024-10-04
00697077003050Amico Diagnostic, Inc.Amico Diagnostic IncorporatedHLI2024-09-18
00697077003043Amico Diagnostic WallboardAmico Diagnostic IncorporatedHLI2024-07-11
00697077003029Amico Diagnostic StationAmico Diagnostic IncorporatedHLI2024-05-02
00857691006039ENFOCUS 2300 INTEGRATED OCTBIOPTIGEN, INC.OBO2024-05-02
04059237000938ANTERIONHeidelberg Engineering GmbHOBO2023-11-18
04059237000945ANTERIONHeidelberg Engineering GmbHOBO2023-11-18
00732094086515Welch Allyn, Inc.WELCH ALLYN, INC.HLI2023-08-17
00732094087727Welch Allyn, Inc.WELCH ALLYN, INC.HLI2023-08-17
00732094089202Welch Allyn, Inc.WELCH ALLYN, INC.HLI2023-08-17
00697077002237Amico Diagnostic WallboardAmico Diagnostic IncorporatedHLI2023-07-27
04987669101568Scanning Laser OphthalmoscopeNIDEK CO.,LTD.OBO2023-06-12
04987669200636Image filing software NAVIS-EXNIDEK CO.,LTD.OBO2023-06-12
04582273604704Cornea/Anterior Segment OCTTOMEY CORPORATION.OBO2023-06-07
04053755119660INDIRECT OPHTHALMOSCOPE BINOCULARHeine Optotechnik GmbH & Co. KGHLI2022-12-15
04053755120307INDIRECT OPHTHALMOSCOPE MONOCULARHeine Optotechnik GmbH & Co. KGHLI2022-12-15
04053755153541OMEGA 500Heine Optotechnik GmbH & Co. KGHLI2022-12-12