510(k) K103645
K103645 is an FDA 510(k) premarket notification submitted by Toshiba Medical Systems Corporation, Japan for the device "APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM". The FDA issued a decision of Substantially Equivalent on Jan 12, 2011. The device falls under product code ITX (Transducer, Ultrasonic, Diagnostic), a Class II device regulated under 21 CFR 892.1570. Toshiba Medical Systems Corporation, Japan has 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 12, 2011
- Date Received
- Dec 13, 2010
- Clearance Type
- Special
- 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)