Digital Expert Access with Remote Scanning
FDA 510(k) K232346 · GE Healthcare
510(k) numberK232346
Submission
- Device name
- Digital Expert Access with Remote Scanning
- Applicant
- GE Healthcare
Chicago, IL, US - Received
- August 4, 2023
- Decision date
- October 27, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Digital Expert Access with Remote Scanning cleared by the FDA?
Digital Expert Access with Remote Scanning (K232346) received a 510(k) decision of Substantially Equivalent on October 27, 2023, 84 days after the submission was received.
What is the product code of K232346?
The FDA product code is LNH – System, Nuclear Magnetic Resonance Imaging, a Class II (moderate risk) device regulated under 21 CFR 892.1000.