Scopix Video Imager
FDA 510(k) K882096 · Agfa-Gevaert, Inc.
510(k) numberK882096
Submission
- Device name
- Scopix Video Imager
- Applicant
- Agfa-Gevaert, Inc.
Ridgefield Park, NJ, US - Received
- May 18, 1988
- Decision date
- August 9, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| K081637 | Laser Imager Drypro Model 873LMC · Special | Konica Minolta Medical & Graphic, Inc. | 07/01/2008SE |
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| K061999 | Dry Laser Imager, Drypro Model 832LMC · Traditional | Konica Minolta Medical & Graphic, Inc. | 08/15/2006SE |
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Questions and answers
When was Scopix Video Imager cleared by the FDA?
Scopix Video Imager (K882096) received a 510(k) decision of Substantially Equivalent on August 9, 1988, 83 days after the submission was received.
What is the product code of K882096?
The FDA product code is LMC – Camera, Multi Format, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2040.