510(k) K253310
K253310 is an FDA 510(k) premarket notification submitted by Esaote, S.P.A. for the device "7600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30)". The FDA issued a decision of Substantially Equivalent on Nov 25, 2025. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550. Esaote, S.P.A. has 68 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 25, 2025
- Date Received
- Sep 29, 2025
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Imaging, Pulsed Doppler, Ultrasonic
- Device Class
- Class II
- Regulation Number
- 892.1550
- Review Panel
- RA
- Submission Type
- 510(k)