Iscan
Ophthalmic Optical Coherence Tomography System
7manufacturers in China registered for this device type
7catalogue numbers in this listing
7510(k) clearances naming this product code
4recalls on this code
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) | K133892 |
| Record published | 2016-08-31 |
| Record revised | 2020-06-05 (version 4) |
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 |
|---|---|---|
| iVue 500 | In distribution | |
| iVue 500 | In distribution | |
| iVue 500 | In distribution | |
| iVue 500 | In distribution | |
| iVue 500 | In distribution | |
| iVue 500 | In distribution | |
| iVue 500 | 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 |
| zumax | Zumax Medical Co., Ltd. | 6 |
| Jedmed | Jedmed Instrument Company | 3 |
| RTVue XR Avanti | Optovue, Inc. | 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 Naming This Product
2 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Optovue, Inc. | 510(k) number | 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 |
| Optovue, Inc. | 510(k) number | 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 |
Recalls
1 of these is 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 |
| 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.