G.E. Polarix II C-Arm
FDA 510(k) K902982 · Electromek Diagnostic Systems, Inc.
510(k) numberK902982
Submission
- Device name
- G.E. Polarix II C-Arm
- Applicant
- Electromek Diagnostic Systems, Inc.
Troy, IL, US - Received
- June 26, 1990
- Decision date
- November 13, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| K902986 | G.E. DXD 325/350/350II/DXD 525/525II GeneratorsIZO · Traditional | 02/13/1991SE |
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| K902985 | G.E. MST 625/625II/MST 1050/1050II Three Phase GenIZO · Traditional | 12/19/1990SE |
| 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 |
| K902984 | G.E. Amx 110, Amx II and Amx 3 X-Ray UnitsIZL · Traditional | 10/26/1990SE |
| K902980 | G.E. XT Ceiling Tube SuspensionJAA · Traditional | 10/23/1990SE |
Questions and answers
When was G.E. Polarix II C-Arm cleared by the FDA?
G.E. Polarix II C-Arm (K902982) received a 510(k) decision of Substantially Equivalent on November 13, 1990, 140 days after the submission was received.
What is the product code of K902982?
The FDA product code is JAA – System, X-Ray, Fluoroscopic, Image-Intensified, a Class II (moderate risk) device regulated under 21 CFR 892.1650.