GE 900
FDA 510(k) K811103 · General Electric Co.
510(k) numberK811103
Submission
- Device name
- GE 900
- Applicant
- General Electric Co.
Mchenry, IL, US - Received
- April 23, 1981
- Decision date
- June 9, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| K252909 | Diagnostic X-Ray Equipment Model POCT22EHD · Traditional | Ningbo Runyes Medical Instrument Co., Ltd. | 02/03/2026SE |
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| K242185 | Rextar ProEHD · Traditional | Raypia Co., Ltd. | 12/04/2024SE |
| K242591 | XERO-alphaEHD · Traditional | DRTECH Corporation | 11/01/2024SE |
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Questions and answers
When was GE 900 cleared by the FDA?
GE 900 (K811103) received a 510(k) decision of Substantially Equivalent on June 9, 1981, 47 days after the submission was received.
What is the product code of K811103?
The FDA product code is EHD – Unit, X-Ray, Extraoral With Timer, a Class II (moderate risk) device regulated under 21 CFR 872.1800.