510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K962955Substantially Equivalent

Gammacon Image Translation System

Medical Imaging Technology Assoc., Inc., Mainland PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K962955 is the FDA 510(k) clearance record for GAMMACON IMAGE TRANSLATION SYSTEM, a class II device, cleared for Medical Imaging Technology Assoc., Inc. on under FDA product code KPS (System, Tomography, Computed, Emission). FDA records list one 510(k) clearance for Medical Imaging Technology Assoc., Inc. As of , FDA records show no recalls naming K962955.

Clearance record

Decision date
Received
(90 days to decision)
Product code
KPS System, Tomography, Computed, Emission
Regulation
21 CFR 892.1200
Device class
Class II
Review panel
Radiology
Applicant
Medical Imaging Technology Assoc., Inc. 29 Main St., Mainland PA
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