510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K934818Substantially Equivalent

Hand Held Dental X-Ray Device

Dept. of the Army, Falls Church VA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K934818 is the FDA 510(k) clearance record for HAND HELD DENTAL X-RAY DEVICE, a class II device, cleared for Dept. of the Army on under FDA product code IZL (System, X-Ray, Mobile). FDA records list 5 510(k) clearances for Dept. of the Army, from to . As of , FDA records show no recalls naming K934818.

Clearance record

Decision date
Received
(109 days to decision)
Product code
IZL System, X-Ray, Mobile
Regulation
21 CFR 892.1720
Device class
Class II
Review panel
Radiology
Applicant
Dept. of the Army 5109 Leesburg Pike, Falls Church VA
510(k) summary
Statement
Third party review
No

Clearances, product code IZL

Trailing 12 months
6 clearances under product code IZL in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code IZL, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20261
March 20261
April 20260
May 20261
June 20261
July 20260
August 20261
September 20260
October 20260