510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K071806Substantially Equivalent

Eclos Computed Tomography X-Ray System

FUJIFILM Healthcare Americas Corporation, Twinsburg OH / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K071806 is the FDA 510(k) clearance record for ECLOS COMPUTED TOMOGRAPHY X-RAY SYSTEM, a class II device, cleared for Hitachi Medical Systems America, Inc. on under FDA product code JAK (System, X-Ray, Tomography, Computed). FDA records list 394 510(k) clearances for FUJIFILM Healthcare Americas Corporation, from to . As of , FDA records show one recall naming K071806.

Clearance record

Decision date
Received
(57 days to decision)
Product code
JAK System, X-Ray, Tomography, Computed
Regulation
21 CFR 892.1750
Device class
Class II
Review panel
Radiology
Applicant
Hitachi Medical Systems America, Inc. 1959 Summit Commerce Park, Twinsburg OH
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JAK

Trailing 12 months
21 clearances under product code JAK in the twelve months to October 2026, March 2026 the highest month at 10.
Show the numbers
Monthly 510(k) clearances under FDA product code JAK, trailing twelve months
MonthClearances
November 20251
December 20250
January 20261
February 20260
March 202610
April 20260
May 20261
June 20262
July 20262
August 20260
September 20264
October 20260