510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K963913Substantially Equivalent

Md100 & Mm150

Konica Medical Corp., New York NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K963913 is the FDA 510(k) clearance record for MD100 & MM150, a class I device, cleared for Konica Medical Corp. on under FDA product code EAM (Screen, Intensifying, Radiographic). FDA records list 12 510(k) clearances for Konica Medical Corp., from to . As of , FDA records show no recalls naming K963913.

Clearance record

Decision date
Received
(373 days to decision)
Product code
EAM Screen, Intensifying, Radiographic
Regulation
21 CFR 892.1960
Device class
Class I
Review panel
Radiology
Applicant
Konica Medical Corp. The Chrysler Bldg., New York NY
510(k) summary
Statement
Third party review
No

Clearances, product code EAM

Trailing 12 months

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

FDA records show no clearances under product code EAM in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code EAM, 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