VERATHON INC. BLADDERSCAN ULTRASOUND SYSTEM, MODEL BVI 9600— 510(k) K082456

Name: FDA 510(k) clearance K082456
Creator: U.S. Food and Drug Administration
Published: 2008-12-01

Substantially Equivalent

Verathon Incorporated

FDA 510(k) clearance K082456 for VERATHON INC. BLADDERSCAN ULTRASOUND SYSTEM, MODEL BVI 9600, Substantially Equivalent on 2008-12-01. Applicant: Verathon Incorporated. Device class: 2.

Clearance details

Applicant: Verathon Incorporated
Product code: Code IYO
Device class: Class 2
Regulation: 21 CFR 892.1560
Advisory panel: Radiology
Date received: 2008-08-26
Decision date: 2008-12-01
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Bothell, WA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code IYO

view all

K253452 — Accuro 3S2026-07-24
K260190 — ARTHUR2026-06-18
K252237 — EdgeFlow UW202026-04-17
K254021 — Accuro XV2026-04-09
K253898 — QT Scanner 2000 Model A2026-03-04

More clearances from Verathon Incorporated

view all

K172356 — BladderScan Prime PLUS System2017-09-15
K153101 — BladderScan Prime System2015-11-19
K090214 — VERATHON INC. BLADDERSCAN BVM 9500 ULTRASOUND2009-03-13
K071217 — BLADDERSCAN BVI 9400 ULTRASOUND2007-05-17

Adverse events under product code IYO

product code IYO

Malfunction: 3,339
Total: 3,339

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K082456

K-number listed on FDA's recall record

Z-1091-2016 — BladderScan BVI 9600, Model Numbers: 0270-0451, 0270-0452, 0270-0754, and U270-0451. AortaScan AMI 9700, Model Numbers: 0270-0636, 0270-0639, and U270-0636.Class II·Terminated·Verathon, Inc.·20151130

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K082456.

Data sourced from openFDA. This site is unofficial and independent of the FDA.