510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K881834Substantially Equivalent

Model Ssd-870 Diagnostic Ultrasound Imaging System

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

K881834 is the FDA 510(k) clearance record for MODEL SSD-870 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM, a class II device, cleared for Ge Medical Systems Information Technologies on under FDA product code IYO (System, Imaging, Pulsed Echo, Ultrasonic). FDA records list 171 510(k) clearances for Ge Medical Systems Information Technologies, from to . As of , FDA records show no recalls naming K881834.

Clearance record

Decision date
Received
(117 days to decision)
Product code
IYO System, Imaging, Pulsed Echo, Ultrasonic
Regulation
21 CFR 892.1560
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 IYO

Trailing 12 months
9 clearances under product code IYO in the twelve months to October 2026, February 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code IYO, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20262
March 20261
April 20262
May 20260
June 20261
July 20261
August 20260
September 20261
October 20261