510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K864136Substantially Equivalent

260Sl Imaging System Small Parts Probes

GE Medical Systems Information Technologies, Inc., Wallingford CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K864136 is the FDA 510(k) clearance record for 260SL IMAGING SYSTEM SMALL PARTS PROBES, a class II device, cleared for Ge Medical Systems Information Technologies on under FDA product code ITX (Transducer, Ultrasonic, Diagnostic). FDA records list 171 510(k) clearances for Ge Medical Systems Information Technologies, from to . As of , FDA records show no recalls naming K864136.

Clearance record

Decision date
Received
(98 days to decision)
Product code
ITX Transducer, Ultrasonic, Diagnostic
Regulation
21 CFR 892.1570
Device class
Class II
Review panel
Radiology
Applicant
Ge Medical Systems Information Technologies 61 Barnes Park Rd. N., Wallingford CT
Third party review
No

Clearances, product code ITX

Trailing 12 months
6 clearances under product code ITX in the twelve months to October 2026, July 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code ITX, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20263
August 20262
September 20261
October 20260