510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K860777Substantially Equivalent

Matrix Ld & Ld/laser Digitizer

Matrix Instruments, Orangeburg NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K860777 is the FDA 510(k) clearance record for MATRIX LD & LD/LASER DIGITIZER, a class II device, cleared for Matrix Instruments on under FDA product code LMA (Digitizer, Image, Radiological). FDA records list 4 510(k) clearances for Matrix Instruments, from to . As of , FDA records show no recalls naming K860777.

Clearance record

Decision date
Received
(415 days to decision)
Product code
LMA Digitizer, Image, Radiological
Regulation
21 CFR 892.2030
Device class
Class II
Review panel
Radiology
Applicant
Matrix Instruments Agfa Corp., Orangeburg NY
Third party review
No

Clearances, product code LMA

Trailing 12 months

FDA records hold no clearances under product code LMA in the trailing twelve months.

FDA records show no clearances under product code LMA in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LMA, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260