GE Definium Amx 700, Model Amx 700
FDA 510(k) K052897 · General Electric Medical Systems
510(k) numberK052897
Submission
- Device name
- GE Definium Amx 700, Model Amx 700
- Applicant
- General Electric Medical Systems
Milwaukee, WI, US - Received
- October 14, 2005
- Decision date
- November 8, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was GE Definium Amx 700, Model Amx 700 cleared by the FDA?
GE Definium Amx 700, Model Amx 700 (K052897) received a 510(k) decision of Substantially Equivalent on November 8, 2005, 25 days after the submission was received.
What is the product code of K052897?
The FDA product code is IZL – System, X-Ray, Mobile, a Class II (moderate risk) device regulated under 21 CFR 892.1720.