| Device Type ID | 4168 |
| Device Name | Camera, Ophthalmic, Ac-powered |
| Regulation Description | Ophthalmic Camera. |
| Regulation Medical Specialty | Ophthalmic |
| Review Panel | Ophthalmic |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Ophthalmic And Ear, Nose And Throat Devices (DOED) Diagnostic And Surgical Devices Branch (DSDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 886.1120 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | HKI |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
|
| Device Type ID | 4168 |
| Device | Camera, Ophthalmic, Ac-powered |
| Product Code | HKI |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Ophthalmic Camera. |
| CFR Regulation Number | 886.1120 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
C.S.O. S.R.L. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CAREFUSION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CRYSTALVUE MEDICAL CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
EYENEZ LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
KEELER LIMITED | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NIDEK CO | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NIDEK CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
OPTOMED OY | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
TEARSCIENCE, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
TOPCON CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
TOPCON CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
TOPCON MEDICAL SYSTEMS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Camera | 31 |
Device Operational Issue | 19 |
Computer Hardware | 14 |
Device Issue | 12 |
Operating System Becomes Nonfunctional | 11 |
Device Inoperable | 7 |
Loss Of Data | 7 |
Connection Problem | 7 |
Device Operates Differently Than Expected | 6 |
Computer Operating System Problem | 6 |
Application Network Problem | 3 |
Poor Quality Image | 3 |
No Device Output | 3 |
Computer Software Problem | 3 |
Device Disinfection Or Sterilization Issue | 3 |
Device Component Or Accessory | 3 |
Motherboard | 3 |
Device Displays Incorrect Message | 3 |
Smoking | 2 |
Use Of Device Problem | 2 |
Programming Issue | 2 |
CPU (Central Processing Unit Of Computer System) | 2 |
Cable | 2 |
Image Resolution Poor | 2 |
Data Problem | 2 |
CPU (Central Processing Unit) Board | 2 |
Application Program Problem | 2 |
Patient Data Problem | 2 |
Network | 1 |
Fumes Or Vapors | 1 |
Environmental Compatibility Problem | 1 |
Installation-Related Problem | 1 |
Operating System Version Or Upgrade Problem | 1 |
System | 1 |
Optical Problem | 1 |
Sensor | 1 |
Loose Or Intermittent Connection | 1 |
Ambient Noise Problem | 1 |
Noise, Audible | 1 |
Crack | 1 |
Corroded | 1 |
Device Stops Intermittently | 1 |
Device Sensing Problem | 1 |
Power Problem | 1 |
Date/Time-Related Software Problem | 1 |
Communication Or Transmission Problem | 1 |
Problem With Software Installation | 1 |
Power Supply | 1 |
Synchronizer | 1 |
Electrical /Electronic Property Problem | 1 |
Electrical Power Problem | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
Optical Distortion | 1 |
| Total Device Problems | 189 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Clarity Medical Systems Inc | II | Mar-20-2014 |
| 2 | Clarity Medical Systems Inc | II | Mar-07-2014 |
| 3 | Merge Healthcare, Inc. | II | Feb-25-2019 |
| 4 | Merge Healthcare, Inc. | II | Feb-06-2017 |
| 5 | Merge Healthcare, Inc. | II | Jan-12-2017 |
| 6 | Nidek Inc | II | Jul-02-2014 |
| 7 | Optovue, Inc. | II | Oct-04-2017 |