510(k) K191495
K191495 is an FDA 510(k) premarket notification submitted by Fujifilm Corporation for the device "Biopsy Positioner". The FDA issued a decision of Substantially Equivalent on July 3, 2019. The device falls under product code IZH (System, X-Ray, Mammographic), a Class II device regulated under 21 CFR 892.1710. Fujifilm Corporation has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 3, 2019
- Date Received
- June 5, 2019
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, X-Ray, Mammographic
- Device Class
- Class II
- Regulation Number
- 892.1710
- Review Panel
- RA
- Submission Type