510(k) K133553
K133553 is an FDA 510(k) premarket notification submitted by Toshiba America Medical Systems, In.C for the device "KALARE". The FDA issued a decision of Substantially Equivalent on June 13, 2014. The device falls under product code JAA (System, X-Ray, Fluoroscopic, Image-Intensified), a Class II device regulated under 21 CFR 892.1650. Toshiba America Medical Systems, In.C has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 13, 2014
- Date Received
- November 19, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, X-Ray, Fluoroscopic, Image-Intensified
- Device Class
- Class II
- Regulation Number
- 892.1650
- Review Panel
- RA
- Submission Type