510(k) K103629
K103629 is an FDA 510(k) premarket notification submitted by Toshiba America Medical Systems, In.C for the device "PET-512MC TRANSESOPHAGEAL TRANSDUCER". The FDA issued a decision of Substantially Equivalent on February 2, 2011. The device falls under product code ITX (Transducer, Ultrasonic, Diagnostic), a Class II device regulated under 21 CFR 892.1570. Toshiba America Medical Systems, In.C has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 2, 2011
- Date Received
- December 13, 2010
- 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