Product code OQT
- Device name
- Prostate Lesion, Documentation, System
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.2050
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Definition
- Produces an elasticity image of the prostate to document prostate abnormalities that were previously identified by digital rectal examination.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records
| 510(k) | Device | Applicant | Decision date |
|---|
| DEN100016 | PROSTATE MECHANICAL IMAGER | Artann Laboratories, Inc. | 2012-04-27 |