Aplio XG Diagnostic Ultrasound System Model SSA-790A Version 4.0
FDA 510(k) K091295 · Toshiba America Medical Systems, In.C
510(k) numberK091295
Submission
- Device name
- Aplio XG Diagnostic Ultrasound System Model SSA-790A Version 4.0
- Applicant
- Toshiba America Medical Systems, In.C
Tustin, CA, US - Received
- May 4, 2009
- Decision date
- May 15, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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Questions and answers
When was Aplio XG Diagnostic Ultrasound System Model SSA-790A Version 4.0 cleared by the FDA?
Aplio XG Diagnostic Ultrasound System Model SSA-790A Version 4.0 (K091295) received a 510(k) decision of Substantially Equivalent on May 15, 2009, 11 days after the submission was received.
What is the product code of K091295?
The FDA product code is ITX – Transducer, Ultrasonic, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 892.1570.