510(k) K120546
K120546 is an FDA 510(k) premarket notification submitted by Toshiba Medical Systems Corporation, Japan for the device "AQUILION PREMIUM". The FDA issued a decision of Substantially Equivalent on Jun 13, 2012. The device falls under product code JAK (System, X-Ray, Tomography, Computed), a Class II device regulated under 21 CFR 892.1750. Toshiba Medical Systems Corporation, Japan has 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 13, 2012
- Date Received
- Feb 23, 2012
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, X-Ray, Tomography, Computed
- Device Class
- Class II
- Regulation Number
- 892.1750
- Review Panel
- RA
- Submission Type
- 510(k)