510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K891386Substantially Equivalent

Cvis Ultra-Scan One Imaging System

Cardiovascular Imaging Systems, Inc., Sunnyvale CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K891386 is the FDA 510(k) clearance record for CVIS ULTRA-SCAN ONE IMAGING SYSTEM, a class II device, cleared for Cardiovascular Imaging Systems, Inc. on under FDA product code IYO (System, Imaging, Pulsed Echo, Ultrasonic). FDA records list 19 510(k) clearances for Cardiovascular Imaging Systems, Inc., from to . As of , FDA records show no recalls naming K891386.

Clearance record

Decision date
Received
(68 days to decision)
Product code
IYO System, Imaging, Pulsed Echo, Ultrasonic
Regulation
21 CFR 892.1560
Device class
Class II
Review panel
Radiology
Applicant
Cardiovascular Imaging Systems, Inc. 595 N. Pastoria Ave., Sunnyvale CA
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