510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K040050Substantially Equivalent

Instatrak System with Multiple Dataset Navigation, Model It3500

GE Medical Systems Navigation and Visualization in, Salt Lake City UT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K040050 is the FDA 510(k) clearance record for INSTATRAK SYSTEM WITH MULTIPLE DATASET NAVIGATION, MODEL IT3500, a class II device, cleared for Ge Medical Systems Navigation and Visualization IN on under FDA product code LLZ (System, Image Processing, Radiological). FDA records list one 510(k) clearance for Ge Medical Systems Navigation and Visualization IN. As of , FDA records show 6 recalls naming K040050.

Clearance record

Decision date
Received
(72 days to decision)
Product code
LLZ System, Image Processing, Radiological
Regulation
21 CFR 892.2050
Device class
Class II
Review panel
Radiology
Applicant
Ge Medical Systems Navigation and Visualization IN 384 Wright Brothers Dr., Salt Lake City UT
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LLZ

Trailing 12 months
47 clearances under product code LLZ in the twelve months to October 2026, July 2026 the highest month at 8.
Show the numbers
Monthly 510(k) clearances under FDA product code LLZ, trailing twelve months
MonthClearances
November 20254
December 20251
January 20263
February 20264
March 20266
April 20262
May 20265
June 20265
July 20268
August 20263
September 20266
October 20260