510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K213620Substantially Equivalent

ATUSA™ Automated 3D Breast Ultrasound System

Isono Health Inc., South San Francisco CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K213620 is the FDA 510(k) clearance record for ATUSA™ Automated 3D Breast Ultrasound System, a class II device, cleared for Isono Health, Inc. on under FDA product code IYO (System, Imaging, Pulsed Echo, Ultrasonic). FDA records list one 510(k) clearance for Isono Health, Inc. As of , FDA records show no recalls naming K213620.

Clearance record

Decision date
Received
(157 days to decision)
Product code
IYO System, Imaging, Pulsed Echo, Ultrasonic
Regulation
21 CFR 892.1560
Device class
Class II
Review panel
Radiology
Applicant
Isono Health, Inc. 395 Oyster Pt. Blvd., South San Francisco CA
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