Shimadzu Whole Body X-Ray Computed Tomography Scanner SCT-7800TC
FDA 510(k) K011141 · Shimadzu Corp.
510(k) numberK011141
Submission
- Device name
- Shimadzu Whole Body X-Ray Computed Tomography Scanner SCT-7800TC
- Applicant
- Shimadzu Corp.
Torrance, CA, US - Received
- April 13, 2001
- Decision date
- July 3, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was Shimadzu Whole Body X-Ray Computed Tomography Scanner SCT-7800TC cleared by the FDA?
Shimadzu Whole Body X-Ray Computed Tomography Scanner SCT-7800TC (K011141) received a 510(k) decision of Substantially Equivalent on July 3, 2001, 81 days after the submission was received.
What is the product code of K011141?
The FDA product code is JAK – System, X-Ray, Tomography, Computed, a Class II (moderate risk) device regulated under 21 CFR 892.1750.