| Device Type ID | 4427 |
| Device Name | System, Image Management, Ophthalmic |
| Regulation Description | Picture Archiving And Communications System. |
| Regulation Medical Specialty | Radiology |
| 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 | 892.2050 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | NFJ |
| 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 | 4427 |
| Device | System, Image Management, Ophthalmic |
| Product Code | NFJ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Picture Archiving And Communications System. |
| CFR Regulation Number | 892.2050 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
CARL ZEISS MEDITEC INC | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
CARL ZEISS MEDITEC, INC. | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
HAAG-STREIT AG | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
HAAG-STREIT HOLDING | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
HILL-ROM, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
HUVITZ CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
INTELLIGENT RETINAL IMAGING SYSTEMS, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
KOWA CO. LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NEUROVISION IMAGING, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NIDEK CO | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
OPTOS PLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SONOMED, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
TOPCON CORP. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
TOPCON CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
TOPCON MEDICAL SYSTEMS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
WELCH ALLYN, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Data Problem | 10 |
Poor Quality Image | 7 |
Patient Data Problem | 7 |
Device Operates Differently Than Expected | 6 |
Computer Software Problem | 4 |
Device Operational Issue | 3 |
Loss Of Data | 3 |
Programming Issue | 2 |
Device Issue | 2 |
Application Program Problem | 2 |
Program Or Algorithm Execution Problem | 1 |
Leak / Splash | 1 |
Disconnection | 1 |
Camera | 1 |
Output Problem | 1 |
Improper Device Output | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
Connection Problem | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
| Total Device Problems | 55 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Carl Zeiss Meditec AG | II | Feb-04-2015 |
| 2 | Haag-Streit USA Inc | II | Mar-20-2017 |
| 3 | Merge Healthcare, Inc. | II | Jul-10-2017 |
| 4 | Merge Healthcare, Inc. | II | Apr-15-2017 |
| 5 | Merge Healthcare, Inc. | II | Mar-13-2017 |
| 6 | Merge Healthcare, Inc. | II | Feb-23-2017 |