ICT-2000, Integrated C-Arm/Table Multipurpose Radiographic/Fluoroscopic Positioning System Model No. 6896.300
FDA 510(k) K962140 · Continental X-Ray Corp.
510(k) numberK962140
Submission
- Device name
- ICT-2000, Integrated C-Arm/Table Multipurpose Radiographic/Fluoroscopic Positioning System Model No. 6896.300
- Applicant
- Continental X-Ray Corp.
Broadview, IL, US - Received
- June 3, 1996
- Decision date
- July 25, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was ICT-2000, Integrated C-Arm/Table Multipurpose Radiographic/Fluoroscopic Positioning System Model No. 6896.300 cleared by the FDA?
ICT-2000, Integrated C-Arm/Table Multipurpose Radiographic/Fluoroscopic Positioning System Model No. 6896.300 (K962140) received a 510(k) decision of Substantially Equivalent on July 25, 1996, 52 days after the submission was received.
What is the product code of K962140?
The FDA product code is JAA – System, X-Ray, Fluoroscopic, Image-Intensified, a Class II (moderate risk) device regulated under 21 CFR 892.1650.