510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
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K042428Substantially Equivalent

Sceptrep3 Pet/ct

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

K042428 is the FDA 510(k) clearance record for SCEPTREP3 PET/CT, a class II device, cleared for Hitachi Medical Systems America, Inc. on under FDA product code KPS (System, Tomography, Computed, Emission). FDA records list 394 510(k) clearances for FUJIFILM Healthcare Americas Corporation, from to . As of , FDA records show 2 recalls naming K042428.

Clearance record

Decision date
Received
(9 days to decision)
Product code
KPS System, Tomography, Computed, Emission
Regulation
21 CFR 892.1200
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
Yes

Clearances, product code KPS

Trailing 12 months
9 clearances under product code KPS in the twelve months to October 2026, December 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code KPS, trailing twelve months
MonthClearances
November 20251
December 20252
January 20261
February 20261
March 20260
April 20261
May 20261
June 20260
July 20261
August 20260
September 20261
October 20260