Matrix LR, LR 22A & Lr/Laser Recorder

FDA 510(k) K860776 · Matrix Instruments

Substantially Equivalent

510(k) numberK860776

Submission

Device name
Matrix LR, LR 22A & Lr/Laser Recorder
Applicant
Matrix Instruments
Orangeburg, NY, US
Received
March 3, 1986
Decision date
June 16, 1986
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
LMC – Camera, Multi Format, Radiological
Device class
Class II (moderate risk)
Regulation
21 CFR 892.2040
Specialty
Radiology

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More from Mitsubishi Electric Corporation Kyoto Works

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K860777Matrix LD & Ld/Laser DigitizerLMA · Traditional 04/22/1987SE
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Questions and answers

When was Matrix LR, LR 22A & Lr/Laser Recorder cleared by the FDA?

Matrix LR, LR 22A & Lr/Laser Recorder (K860776) received a 510(k) decision of Substantially Equivalent on June 16, 1986, 105 days after the submission was received.

What is the product code of K860776?

The FDA product code is LMC – Camera, Multi Format, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2040.