510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K844120Substantially Equivalent

Ultrasonic Scanner Calibration & Test Objects

Echo Ultrasound, Lewistown PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K844120 is the FDA 510(k) clearance record for ULTRASONIC SCANNER CALIBRATION & TEST OBJECTS, a class I device, cleared for Echo Ultrasound on under FDA product code GXX (Block, Test, Ultrasonic Scanner Calibration). FDA records list 6 510(k) clearances for Echo Ultrasound, from to . As of , FDA records show no recalls naming K844120.

Clearance record

Decision date
Received
(92 days to decision)
Product code
GXX Block, Test, Ultrasonic Scanner Calibration
Regulation
21 CFR 882.1925
Device class
Class I
Review panel
Neurology
Applicant
Echo Ultrasound Post Office Box 552, Lewistown PA
Third party review
No

Clearances, product code GXX

Trailing 12 months

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

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