CT Colonography II
FDA 510(k) K041270 · General Electric Medical Systems
510(k) numberK041270
Submission
- Device name
- CT Colonography II
- Applicant
- General Electric Medical Systems
Waukesha, WI, US - Received
- May 12, 2004
- Decision date
- May 27, 2004
- 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 CT Colonography II cleared by the FDA?
CT Colonography II (K041270) received a 510(k) decision of Substantially Equivalent on May 27, 2004, 15 days after the submission was received.
What is the product code of K041270?
The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.