510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K984156Substantially Equivalent

Shimadzu Whole Body X-Ray Computed Tomography Scanner Sct-7000Tx W/fluro Option

Shimadzu Medical Systems, Torrance CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K984156 is the FDA 510(k) clearance record for SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7000TX W/FLURO OPTION, a class II device, cleared for Shimadzu Medical Systems on under FDA product code JAK (System, X-Ray, Tomography, Computed). FDA records list 90 510(k) clearances for Shimadzu Medical Systems, from to . As of , FDA records show no recalls naming K984156.

Clearance record

Decision date
Received
(153 days to decision)
Product code
JAK System, X-Ray, Tomography, Computed
Regulation
21 CFR 892.1750
Device class
Class II
Review panel
Radiology
Applicant
Shimadzu Medical Systems 20101 S. Vermont Ave., Torrance CA
510(k) summary
Statement
Third party review
No

Clearances, product code JAK

Trailing 12 months
20 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 20263
October 20260