510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K961597Substantially Equivalent

Gated Mibi 3-D Ejection Fraction Processing

Trionix Research Laboratory, Inc., Twinsburg OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K961597 is the FDA 510(k) clearance record for GATED MIBI 3-D EJECTION FRACTION PROCESSING, a class II device, cleared for Trionix Research Laboratory, Inc. on under FDA product code KPS (System, Tomography, Computed, Emission). FDA records list 16 510(k) clearances for Trionix Research Laboratory, Inc., from to . As of , FDA records show no recalls naming K961597.

Clearance record

Decision date
Received
(133 days to decision)
Product code
KPS System, Tomography, Computed, Emission
Regulation
21 CFR 892.1200
Device class
Class II
Review panel
Radiology
Applicant
Trionix Research Laboratory, Inc. 8037 Bavaria Rd., Twinsburg OH
510(k) summary
Statement
Third party review
No

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