Definition: Collection Of Light Signals For Visualization Of Cellular Microstructures.
| Device Type ID | 5465 |
| Device Name | Confocal Optical Imaging |
| Physical State | Usually Include Optical Fibers, Light Collection Cameras And Computer-based Central Processing Unit |
| Technical Method | Collects Reflected And Scattered Light Signals From The Areas Of Interest For Image Reconstruction |
| Target Area | Soft Tissue, Blood Vessel And Other Vessels In The Body |
| Regulation Description | Endoscope And Accessories. |
| Regulation Medical Specialty | Gastroenterology/Urology |
| Review Panel | General & Plastic Surgery |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) General Surgery Devices Branch Two - Surgical (GSDB2) |
| Submission Type | 510(k) |
| CFR Regulation Number | 876.1500 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OWN |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5465 |
| Device | Confocal Optical Imaging |
| Product Code | OWN |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Endoscope And Accessories. |
| CFR Regulation Number | 876.1500 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
DANIEL & DANIEL CONSULTING | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
FLUOPTICS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
KARL STORZ GMBH & CO. KG | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
KARL STORZ SE & CO KG | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
MAUNA KEA TECHNOLOGIES | ||
SUBSTANTIALLY EQUIVALENT | 8 | |
MEDTRONIC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDTRONIC, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
QUEST MEDICAL IMAGING | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
STRYKER | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
STRYKER CORP. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
VISIONSENSE LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Loss Of Power | 1 |
Failure To Power Up | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
No Display / Image | 1 |
| Total Device Problems | 4 |