510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K172056Substantially Equivalent

InnoSight Diagnostic Ultrasound System

Qisda Corporation, Taoyuan City, TW / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K172056 is the FDA 510(k) clearance record for InnoSight Diagnostic Ultrasound System, a class II device, cleared for Qisda Corporation on under FDA product code IYO (System, Imaging, Pulsed Echo, Ultrasonic). FDA records list 2 510(k) clearances for Qisda Corporation, from to . As of , FDA records show no recalls naming K172056.

Clearance record

Decision date
Received
(160 days to decision)
Product code
IYO System, Imaging, Pulsed Echo, Ultrasonic
Regulation
21 CFR 892.1560
Device class
Class II
Review panel
Radiology
Applicant
Qisda Corporation #157, Shanying Rd., Gueishan Dist,, Taoyuan City, TW
510(k) summary
Summary PDF
Third party review
No

Clearances, product code IYO

Trailing 12 months
8 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 20260