OQT — Prostate Lesion, Documentation, System Class II
FDA product code OQT covers "Prostate Lesion, Documentation, System", a Class II medical device regulated under 21 CFR 876.2050. Submissions are reviewed by the Gastroenterology, Urology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- OQT
- Device Class
- Class II
- Regulation Number
- 876.2050
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Definition
Produces an elasticity image of the prostate to document prostate abnormalities that were previously identified by digital rectal examination.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN100016 | artann laboratories | PROSTATE MECHANICAL IMAGER | April 27, 2012 |