RTVue XR Avanti
The RTVue XR Avanti is an optical coherence tomography system that images eye structures using low coherence interferometry. It produces cross-sectional views and measurements of the…
The RTVue XR Avanti is an optical coherence tomography system that images eye structures using low coherence interferometry. It produces cross-sectional views and measurements of the retina, retinal nerve fiber layer and optic disc to support assessment of ocular disease.
A computer controls scanning and analysis, assembling retinal structure from sequential depth scans. The system provides retinal and glaucoma scan types and can compare selected measurements with a normative database for clinical reference.
Listed Item
Ophthalmic Optical Coherence Tomography System with 100/240V Table
Anterior Eye Imaging
Corneal and anterior eye scanning requires the CAM auxiliary lens attachment and corresponding software functions. An optional AngioVue module adds motion-contrast visualization of retinal and choroidal vessels; that function depends on the installed software configuration.
Who Else Makes It
Concentrated in Jiangsu (5), Beijing (1), Jiangxi (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Beijing Hongdee Corporation | Beijing | Beijing | Private-label distributor | 43 |
| Lianyungang Tiannuo Optical Instrument Co., Ltd. | Lianyungang | Jiangsu | Contract manufacturer | 31 |
| Shanghai Link Instruments Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 21 |
| Zumax Medical Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Suzhou Raish Meditech Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 4 |
| Jiang XI BIG Vision Medical Technology Co., Ltd. | Ganzhou | Jiangxi | Manufacturer | 3 |
| Robotrak Technologies Co., Ltd. | Nanjing | Jiangsu | Manufacturer | 1 |
Record
| Listed by | Optovue, Inc., United States |
|---|---|
| FDA product code | HLI |
| Device type | Ophthalmoscope, Ac-Powered |
| Device class | Class 2 |
| Regulation | 21 CFR 886.1570 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K153080 |
| Record published | 2020-02-03 |
| Record revised | 2020-06-05 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 100 | In distribution | |
| 100 | In distribution | |
| 100 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Welch Allyn, Inc. | Welch Allyn, Inc. | 90 |
| Amico Diagnostic Station | Amico Diagnostic Incorporated | 55 |
| iVue | Optovue, Inc. | 27 |
| Amico Diagnostic Wallboard | Amico Diagnostic Incorporated | 19 |
| Amico Diagnostic Rollstand | Amico Diagnostic Incorporated | 14 |
| iScan | Optovue, Inc. | 7 |
| zumax | Zumax Medical Co., Ltd. | 6 |
| Jedmed | Jedmed Instrument Company | 3 |
| Amico Diagnostic Ophthalmoscope | Amico Diagnostic Incorporated | 3 |
| Laser Speckle Flowgraphy Lsfg-Navi | Softcare Co., Ltd. | 2 |
| Panoramic Ophthalmoscope | Optos Public Limited Company | 1 |
| 2.8v Specialist ophthalmoscope head & bulb | Keeler Ltd. | 1 |
Showing 12 of 46. All products under Ophthalmoscope, Ac-Powered
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K153080 | 2016-02-11 |
| K133892 | 2014-03-19 |
| K121739 | 2013-01-18 |
| K120238 | 2012-04-03 |
| K103266 | 2011-06-03 |
| K101505 | 2010-09-15 |
| K100861 | 2010-06-17 |
Recalls
3 of these are Class II. Class II means a temporary or reversible health consequence. Class III is unlikely to cause harm at all → typically a labelling or documentation fault. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2017-07-27 | Class II | Other | FDA determined that a 510(k) is needed for the Vault Mapping software (also known as Lens Fitting). | 326 devices | 2021-04-12 |
| 2017-07-27 | Class II | Other | FDA determined that a 510(k) is needed for the Vault Mapping software (also known as Lens Fitting). | 326 devices | 2021-04-12 |
| 2016-03-16 | Class II | Under Investigation by firm | A software anomaly was detected that affects Optovue iVue and iVue 500 with Normative Database that may display images of the same eye rather than right and left if user scrolls on the map. | 40 | 2017-04-04 |
| 2013-05-14 | Class III | Software design | Colors from the NDB comparison for Ganglion Cell Complex thickness in the singular OU report in iVue version 3.0 (US) and 3.1(international) are different from those in the individual iWellness ID and OS reports. | ~329 users | 2013-10-24 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.