510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K984466Substantially Equivalent

Dilon 2000, Model 2000-6X8 and Dilon 2000, Model 2000-5X5

Dilon Technologies Inc, Newport News VA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K984466 is the FDA 510(k) clearance record for DILON 2000, MODEL 2000-6X8 AND DILON 2000, MODEL 2000-5X5, a class I device, cleared for Dilon Technologies, Inc. on under FDA product code IYX (Camera, Scintillation (Gamma)). FDA records list 3 510(k) clearances for Dilon Technologies, Inc., from to . As of , FDA records show no recalls naming K984466.

Clearance record

Decision date
Received
(90 days to decision)
Product code
IYX Camera, Scintillation (Gamma)
Regulation
21 CFR 892.1100
Device class
Class I
Review panel
Radiology
Applicant
Dilon Technologies, Inc. 12050 Jefferson Ave.,, Newport News VA
510(k) summary
Summary
Third party review
No

Clearances, product code IYX

Trailing 12 months

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

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