510(k) K172188
K172188 is an FDA 510(k) premarket notification submitted by Toshiba Medical Systems Coroporation for the device "Aquilion Prime SP, TSX-303B/1, v8.4". The FDA issued a decision of Substantially Equivalent on Oct 6, 2017. 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 Coroporation has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 6, 2017
- Date Received
- Jul 20, 2017
- Clearance Type
- Traditional
- 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)