510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K880217Substantially Equivalent

Ssd-870 Cardio Vascular Phased Array Sector Scann.

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

K880217 is the FDA 510(k) clearance record for SSD-870 CARDIO VASCULAR PHASED ARRAY SECTOR SCANN., a class II device, cleared for Ge Medical Systems Information Technologies on under FDA product code DXK (Echocardiograph). FDA records list 171 510(k) clearances for Ge Medical Systems Information Technologies, from to . As of , FDA records show no recalls naming K880217.

Clearance record

Decision date
Received
(96 days to decision)
Product code
DXK Echocardiograph
Regulation
21 CFR 870.2330
Device class
Class II
Review panel
Cardiovascular
Applicant
Ge Medical Systems Information Technologies 61 Barnes Park Rd. N., Wallingford CT
Third party review
No

Clearances, product code DXK

Trailing 12 months

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

FDA records show no clearances under product code DXK in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DXK, 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