Definition: Viewing, Imaging, Measurement, And Analysis Of Ocular Structures. Diagnostic Device To Aid In The Detection And Management Of Various Ocular Diseases.
| Device Type ID | 4395 |
| Device Name | Tomography, Optical Coherence |
| Physical State | Computerized Imaging Device Consisting Of Light Sources And Beam Delivery And Scanning Optics. |
| Technical Method | Cross Sectional Tomograms Of Ocular Structures Are Obtained Using Non-invasive, Non-contact, Low-coherence Optical Interferometry. |
| Target Area | Eye. |
| Regulation Description | Ophthalmoscope. |
| 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 | 886.1570 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OBO |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4395 |
| Device | Tomography, Optical Coherence |
| Product Code | OBO |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Ophthalmoscope. |
| CFR Regulation Number | 886.1570 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BIOPTIGEN, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CARL ZEISS MEDITEC INC | ||
SUBSTANTIALLY EQUIVALENT | 6 | |
CARL ZEISS MEDITEC, INC. | ||
SUBSTANTIALLY EQUIVALENT | 7 | |
HEIDELBERG ENGINEERING GMBH | ||
SUBSTANTIALLY EQUIVALENT | 5 | |
NIDEK CO | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NIDEK CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
OPTOS PLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
OPTOVUE, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
TOPCON CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
| Device Problems | |
|---|---|
Electrical Shorting | 1 |
Break | 1 |
Unintended Electrical Shock | 1 |
| Total Device Problems | 3 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Heidelberg Engineering | II | Apr-26-2018 |