510(k) DEN100016
DEN100016 is an FDA 510(k) premarket notification submitted by Artann Laboratories, Inc. for the device "PROSTATE MECHANICAL IMAGER". The FDA issued a decision of De Novo Granted on April 27, 2012. The device falls under product code OQT (Prostate Lesion, Documentation, System), a Class II device regulated under 21 CFR 876.2050.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- April 27, 2012
- Date Received
- May 21, 2010
- Clearance Type
- Post-NSE
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prostate Lesion, Documentation, System
- Device Class
- Class II
- Regulation Number
- 876.2050
- Review Panel
- GU
- Submission Type
Produces an elasticity image of the prostate to document prostate abnormalities that were previously identified by digital rectal examination.