Definition: This Device Uses Back-reflected Light To Create Two-dimensional Images Versus Back-reflected Sound Waves As Are Used In Ultrasound Imaging.
| Device Type ID | 5483 |
| Device Name | System, Imaging, Optical Coherence Tomography (oct) |
| Regulation Description | Ultrasonic Pulsed Echo Imaging System. |
| Regulation Medical Specialty | Radiology |
| Review Panel | General & Plastic Surgery |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) General Surgery Devices Branch One - Light Based/Laser (GSDB1) |
| Submission Type | 510(k) |
| CFR Regulation Number | 892.1560 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | NQQ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5483 |
| Device | System, Imaging, Optical Coherence Tomography (oct) |
| Product Code | NQQ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Ultrasonic Pulsed Echo Imaging System. |
| CFR Regulation Number | 892.1560 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
AGFA HEALTHCARE N.V. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DIAGNOSTIC PHOTONICS, INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
LIGHTLAB IMAGING, INC. | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
LIGHTLAB IMAGING,INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MICHELSON DIAGNOSTICS LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NINEPOINT MEDICAL | ||
SE - WITH LIMITATIONS | 3 | |
NINEPOINT MEDICAL, INC | ||
SE - WITH LIMITATIONS | 1 | |
PERIMETER MEDICAL IMAGING, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SE - WITH LIMITATIONS | 2 | |
ST. JUDE MEDICAL (ABBOTT LABORATORIES) | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Detachment Of Device Component | 5 |
Adverse Event Without Identified Device Or Use Problem | 2 |
Electrical /Electronic Property Problem | 1 |
| Total Device Problems | 8 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Ninepoint Medical Inc. | II | May-09-2018 |