Suresubtraction Lung
FDA 510(k) K133324 · Toshiba Medical Systems Corporation, Japan
510(k) numberK133324
Submission
- Device name
- Suresubtraction Lung
- Applicant
- Toshiba Medical Systems Corporation, Japan
Tustin, CA, US - Received
- October 29, 2013
- Decision date
- September 5, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Suresubtraction Lung cleared by the FDA?
Suresubtraction Lung (K133324) received a 510(k) decision of Substantially Equivalent on September 5, 2014, 311 days after the submission was received.
What is the product code of K133324?
The FDA product code is JAK – System, X-Ray, Tomography, Computed, a Class II (moderate risk) device regulated under 21 CFR 892.1750.