GE Tethered Portable Digital Radiographic Detector
FDA 510(k) K041922 · General Electric Co.
510(k) numberK041922
Submission
- Device name
- GE Tethered Portable Digital Radiographic Detector
- Applicant
- General Electric Co.
Milwaukee, WI, US - Received
- July 16, 2004
- Decision date
- July 28, 2004
- 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 Tethered Portable Digital Radiographic Detector cleared by the FDA?
GE Tethered Portable Digital Radiographic Detector (K041922) received a 510(k) decision of Substantially Equivalent on July 28, 2004, 12 days after the submission was received.
What is the product code of K041922?
The FDA product code is IZL – System, X-Ray, Mobile, a Class II (moderate risk) device regulated under 21 CFR 892.1720.