510(k) K171738
K171738 is an FDA 510(k) premarket notification submitted by Hitachi Healthcare Americas Corporation for the device "Supria True64". The FDA issued a decision of Substantially Equivalent on August 18, 2017. The device falls under product code JAK (System, X-Ray, Tomography, Computed), a Class II device regulated under 21 CFR 892.1750. Hitachi Healthcare Americas Corporation has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 18, 2017
- Date Received
- June 12, 2017
- 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