X-Ray TV System Sonial Vision G4
FDA 510(k) K131075 · Shimadzu Corp.
510(k) numberK131075
Submission
- Device name
- X-Ray TV System Sonial Vision G4
- Applicant
- Shimadzu Corp.
Torrance, CA, US - Received
- April 17, 2013
- Decision date
- March 28, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
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| K142341 | X-Ray TV System Sonialvision G4JAA · Abbreviated | 03/06/2015SE |
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Questions and answers
When was X-Ray TV System Sonial Vision G4 cleared by the FDA?
X-Ray TV System Sonial Vision G4 (K131075) received a 510(k) decision of Substantially Equivalent on March 28, 2014, 345 days after the submission was received.
What is the product code of K131075?
The FDA product code is JAA – System, X-Ray, Fluoroscopic, Image-Intensified, a Class II (moderate risk) device regulated under 21 CFR 892.1650.