Matrix Video Imager 1020 Compact Camer

FDA 510(k) K842495 · Matrix Instruments

Substantially Equivalent

510(k) numberK842495

Submission

Device name
Matrix Video Imager 1020 Compact Camer
Applicant
Matrix Instruments
Mchenry, IL, US
Received
June 26, 1984
Decision date
August 17, 1984
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
IZI – System, X-Ray, Angiographic
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1600
Specialty
Radiology

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More from Surgvision GmbH

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Questions and answers

When was Matrix Video Imager 1020 Compact Camer cleared by the FDA?

Matrix Video Imager 1020 Compact Camer (K842495) received a 510(k) decision of Substantially Equivalent on August 17, 1984, 52 days after the submission was received.

What is the product code of K842495?

The FDA product code is IZI – System, X-Ray, Angiographic, a Class II (moderate risk) device regulated under 21 CFR 892.1600.