C-Arm X-Ray System
FDA 510(k) K771051 · General Electric Co.
510(k) numberK771051
Submission
- Device name
- C-Arm X-Ray System
- Applicant
- General Electric Co.
Mchenry, IL, US - Received
- June 9, 1977
- Decision date
- June 24, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| K252000 | uDR Arria & uDR ArisKPR · Traditional | Shanghai United Imaging Healthcare Co., Ltd. | 11/26/2025SE |
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Questions and answers
When was C-Arm X-Ray System cleared by the FDA?
C-Arm X-Ray System (K771051) received a 510(k) decision of Substantially Equivalent on June 24, 1977, 15 days after the submission was received.
What is the product code of K771051?
The FDA product code is KPR – System, X-Ray, Stationary, a Class II (moderate risk) device regulated under 21 CFR 892.1680.