Aplio XG Diagnostic Ultrasound System
FDA 510(k) K103645 · Toshiba Medical Systems Corporation, Japan
510(k) numberK103645
Submission
- Device name
- Aplio XG Diagnostic Ultrasound System
- Applicant
- Toshiba Medical Systems Corporation, Japan
Tustin, CA, US - Received
- December 13, 2010
- Decision date
- January 12, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was Aplio XG Diagnostic Ultrasound System cleared by the FDA?
Aplio XG Diagnostic Ultrasound System (K103645) received a 510(k) decision of Substantially Equivalent on January 12, 2011, 30 days after the submission was received.
What is the product code of K103645?
The FDA product code is ITX – Transducer, Ultrasonic, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 892.1570.