510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K842261Substantially Equivalent

Ob Ultrasound Linear Scanner 630

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

K842261 is the FDA 510(k) clearance record for OB ULTRASOUND LINEAR SCANNER 630, a class II device, cleared for Ge Medical Systems Information Technologies on under FDA product code HEM (Imager, Ultrasonic Obstetric-Gynecologic). FDA records list 171 510(k) clearances for Ge Medical Systems Information Technologies, from to . As of , FDA records show no recalls naming K842261.

Clearance record

Decision date
Received
(104 days to decision)
Product code
HEM Imager, Ultrasonic Obstetric-Gynecologic
Regulation
21 CFR 884.2225
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Ge Medical Systems Information Technologies 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code HEM

Trailing 12 months

FDA records hold no clearances under product code HEM in the trailing twelve months.

FDA records show no clearances under product code HEM in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HEM, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260