510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K061028Substantially Equivalent

Precision Thunis 800+

GE Healthcare, Waukesha WI / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K061028 is the FDA 510(k) clearance record for PRECISION THUNIS 800+, a class II device, cleared for Ge Medical Systems, LLC on under FDA product code JAA (System, X-Ray, Fluoroscopic, Image-Intensified). FDA records list 888 510(k) clearances for GE HEALTHCARE, from to . As of , FDA records show no recalls naming K061028.

Clearance record

Decision date
Received
(55 days to decision)
Product code
JAA System, X-Ray, Fluoroscopic, Image-Intensified
Regulation
21 CFR 892.1650
Device class
Class II
Review panel
Radiology
Applicant
Ge Medical Systems, LLC 3000 N. Grandview Blvd., Waukesha WI
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JAA

Trailing 12 months
1 clearance under product code JAA in the twelve months to November 2026, May 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code JAA, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260