Optima XR240amx
FDA 510(k) K182234 · Ge Medical Systems, LLC
510(k) numberK182234
Submission
- Device name
- Optima XR240amx
- Applicant
- Ge Medical Systems, LLC
Waukesha, WI, US - Received
- August 17, 2018
- Decision date
- September 6, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Optima XR240amx cleared by the FDA?
Optima XR240amx (K182234) received a 510(k) decision of Substantially Equivalent on September 6, 2018, 20 days after the submission was received.
What is the product code of K182234?
The FDA product code is IZL – System, X-Ray, Mobile, a Class II (moderate risk) device regulated under 21 CFR 892.1720.