510(k) K233583
K233583 is an FDA 510(k) premarket notification submitted by FUJIFILM Healthcare Americas Corporation for the device "FCT iSTREAM Phase 1". The FDA issued a decision of Substantially Equivalent on April 26, 2024. The device falls under product code JAK (System, X-Ray, Tomography, Computed), a Class II device regulated under 21 CFR 892.1750. FUJIFILM Healthcare Americas Corporation has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 26, 2024
- Date Received
- November 7, 2023
- 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