510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K911749Substantially Equivalent

L-Linex-Ray Fluorescence

Montifore Medical Center, Bronx NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K911749 is the FDA 510(k) clearance record for L-LINEX-RAY FLUORESCENCE, a class II device, cleared for Montifore Medical Center on under FDA product code JAO (Scanner, Fluorescent). FDA records list one 510(k) clearance for Montifore Medical Center. As of , FDA records show no recalls naming K911749.

Clearance record

Decision date
Received
(124 days to decision)
Product code
JAO Scanner, Fluorescent
Regulation
21 CFR 892.1220
Device class
Class II
Review panel
Radiology
Applicant
Montifore Medical Center 111 E 210th St., Bronx NY
510(k) summary
Summary
Third party review
No

Clearances, product code JAO

Trailing 12 months

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

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