Prostate Lesion, Documentation, System
The Prostate Lesion Documentation System (product code OQT) is an ultrasound-based elasticity imaging device that produces images of the prostate to document prostate abnormalities previously identified by digital rectal examination. It uses tissue elasticity measurement to assist in characterizing prostate lesions and supports clinical decision-making in conjunction with other findings. As an FDA Class 2 device under regulation 876.2050, it requires 510(k) premarket clearance and falls within the Gastroenterology and Urology specialty. The device is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- OQT
- Device Class
- FDA class 2
- Regulation Number
- 876.2050
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 1
Device Characteristics
Definition
Produces an elasticity image of the prostate to document prostate abnormalities that were previously identified by digital rectal examination.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| DEN100016 | PROSTATE MECHANICAL IMAGER | Apr 27, 2012 | Unknown | Artann Laboratories, Inc. |