G.E. Amx 110, Amx II and Amx 3 X-Ray Units
FDA 510(k) K902984 · Electromek Diagnostic Systems, Inc.
510(k) numberK902984
Submission
- Device name
- G.E. Amx 110, Amx II and Amx 3 X-Ray Units
- Applicant
- Electromek Diagnostic Systems, Inc.
Troy, IL, US - Received
- June 26, 1990
- Decision date
- October 26, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| K902982 | G.E. Polarix II C-ArmJAA · Traditional | 11/13/1990SE |
| K902981 | G.E. Fluorocon 300 Imaging SystemJAA · Traditional | 11/07/1990SE |
| K902983 | Siemen's Siremobile II C-ArmJAA · Traditional | 11/06/1990SE |
| K902989 | G.E. Monitrol 90 and G.E. Monitrol 15IXR · Traditional | 10/29/1990SE |
| K902791 | G.E. 48-4 Ceiling TubehangerKPR · Traditional | 10/29/1990SE |
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Questions and answers
When was G.E. Amx 110, Amx II and Amx 3 X-Ray Units cleared by the FDA?
G.E. Amx 110, Amx II and Amx 3 X-Ray Units (K902984) received a 510(k) decision of Substantially Equivalent on October 26, 1990, 122 days after the submission was received.
What is the product code of K902984?
The FDA product code is IZL – System, X-Ray, Mobile, a Class II (moderate risk) device regulated under 21 CFR 892.1720.