510(k) K261170
K261170 is an FDA 510(k) premarket notification submitted by Fujifilm Corporation for the device "BA-004CC". The FDA issued a decision of Substantially Equivalent on Aug 12, 2026. The device falls under product code ITX (Transducer, Ultrasonic, Diagnostic), a Class II device regulated under 21 CFR 892.1570. Fujifilm Corporation has 70 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 12, 2026
- Date Received
- Apr 9, 2026
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Transducer, Ultrasonic, Diagnostic
- Device Class
- Class II
- Regulation Number
- 892.1570
- Review Panel
- RA
- Submission Type
- 510(k)