OQT
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Prostate Lesion, Documentation, System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.2050
- Medical specialty
- Gastroenterology, Urology
- FDA definition
- Produces an elasticity image of the prostate to document prostate abnormalities that were previously identified by digital rectal examination.
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| Record | Firm | Date | Builder |
|---|---|---|---|
| PROSTATE MECHANICAL IMAGER (DEN100016) | Artann Laboratories, Inc. | 2012-04-27 |
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