510(k) K242662
K242662 is an FDA 510(k) premarket notification submitted by Viasonix , Ltd. for the device "Falcon/Xpress (Falcon/Xpress)". The FDA issued a decision of Substantially Equivalent on Dec 18, 2024. The device falls under product code JOP (Transducer, Ultrasonic), a Class II device regulated under 21 CFR 870.2880. Viasonix , Ltd. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 18, 2024
- Date Received
- Sep 4, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Transducer, Ultrasonic
- Device Class
- Class II
- Regulation Number
- 870.2880
- Review Panel
- CV
- Submission Type