Matrix LD & Ld/Laser Digitizer

FDA 510(k) K860777 · Matrix Instruments

Substantially Equivalent

510(k) numberK860777

Submission

Device name
Matrix LD & Ld/Laser Digitizer
Applicant
Matrix Instruments
Orangeburg, NY, US
Received
March 3, 1986
Decision date
April 22, 1987
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
LMA – Digitizer, Image, Radiological
Device class
Class II (moderate risk)
Regulation
21 CFR 892.2030
Specialty
Radiology

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More from Pyramid Medical, Inc.

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K860776Matrix LR, LR 22A & Lr/Laser RecorderLMC · Traditional 06/16/1986SE
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Questions and answers

When was Matrix LD & Ld/Laser Digitizer cleared by the FDA?

Matrix LD & Ld/Laser Digitizer (K860777) received a 510(k) decision of Substantially Equivalent on April 22, 1987, 415 days after the submission was received.

What is the product code of K860777?

The FDA product code is LMA – Digitizer, Image, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2030.