510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K113612Substantially Equivalent

Aida V1.5 Diagnostic Ultrasound System Gm-72P00a

Panasonic Healthcare Co., Ltd., Issaquah WA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K113612 is the FDA 510(k) clearance record for AIDA V1.5 DIAGNOSTIC ULTRASOUND SYSTEM GM-72P00A, a class II device, cleared for Panasonic Healthcare Co., Ltd. on under FDA product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic). FDA records list 3 510(k) clearances for Panasonic Healthcare Co., Ltd., from to . As of , FDA records show no recalls naming K113612.

Clearance record

Decision date
Received
(66 days to decision)
Product code
IYN System, Imaging, Pulsed Doppler, Ultrasonic
Regulation
21 CFR 892.1550
Device class
Class II
Review panel
Radiology
Applicant
Panasonic Healthcare Co., Ltd. 2425 Squak Mountain Loop SW, Issaquah WA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code IYN

Trailing 12 months
53 clearances under product code IYN in the twelve months to October 2026, May 2026 the highest month at 11.
Show the numbers
Monthly 510(k) clearances under FDA product code IYN, trailing twelve months
MonthClearances
November 20256
December 20256
January 20264
February 20261
March 20266
April 20263
May 202611
June 20263
July 20266
August 20263
September 20263
October 20261