510(k) K170177
K170177 is an FDA 510(k) premarket notification submitted by Toshibamedical Systems Corporation for the device "Aquilion ONE (TSX-305A/3) V8.3 with FIRST 2.1". The FDA issued a decision of Substantially Equivalent on Jun 30, 2017. The device falls under product code JAK (System, X-Ray, Tomography, Computed), a Class II device regulated under 21 CFR 892.1750. Toshibamedical Systems Corporation has 79 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 30, 2017
- Date Received
- Jan 19, 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)