510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K781177Substantially Equivalent

Ultrasound Breast Scanning Device

Life Instrument Corp., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K781177 is the FDA 510(k) clearance record for ULTRASOUND BREAST SCANNING DEVICE, a class II device, cleared for Life Instrument Corp. on under FDA product code IYO (System, Imaging, Pulsed Echo, Ultrasonic). FDA records list one 510(k) clearance for Life Instrument Corp. As of , FDA records show no recalls naming K781177.

Clearance record

Decision date
Received
(181 days to decision)
Product code
IYO System, Imaging, Pulsed Echo, Ultrasonic
Regulation
21 CFR 892.1560
Device class
Class II
Review panel
Radiology
Applicant
Life Instrument Corp. 4221 Richmond Rd., NW, Walker MI
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