510(k) K192188
K192188 is an FDA 510(k) premarket notification submitted by Canon Medical Systems Corporation for the device "Aquilion ONE (TSX-306A/3) V10.0". The FDA issued a decision of Substantially Equivalent on Sep 6, 2019. The device falls under product code JAK (System, X-Ray, Tomography, Computed), a Class II device regulated under 21 CFR 892.1750. Canon Medical Systems Corporation has 96 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 6, 2019
- Date Received
- Aug 13, 2019
- 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)