LC Positioner
FDA 510(k) K981414 · Fischer Imaging Corp.
510(k) numberK981414
Submission
- Device name
- LC Positioner
- Applicant
- Fischer Imaging Corp.
Denver, CO, US - Received
- April 20, 1998
- Decision date
- July 16, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was LC Positioner cleared by the FDA?
LC Positioner (K981414) received a 510(k) decision of Substantially Equivalent on July 16, 1998, 87 days after the submission was received.
What is the product code of K981414?
The FDA product code is JAA – System, X-Ray, Fluoroscopic, Image-Intensified, a Class II (moderate risk) device regulated under 21 CFR 892.1650.