IntraSight Mobile— 510(k) K203719

Name: FDA 510(k) clearance K203719
Creator: U.S. Food and Drug Administration
Published: 2021-01-19

Substantially Equivalent

Volcano Corporation

FDA 510(k) clearance K203719 for IntraSight Mobile, Substantially Equivalent on 2021-01-19. Applicant: Volcano Corporation. Device class: 2.

Clearance details

Applicant: Volcano Corporation
Product code: Code IYO
Device class: Class 2
Regulation: 21 CFR 892.1560
Advisory panel: Radiology
Date received: 2020-12-21
Decision date: 2021-01-19
Decision: Substantially Equivalent
Clearance type: Special
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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K190626 — SyncVision System2019-04-12
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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 K203719

K-number listed on FDA's recall record

Z-0901-2022 — IntraSight Mobile IVUS Systems, Model: 797415, Part numbers: 300002018101, 300002018102Class III·Ongoing·Volcano Corp·20220124

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K203719.

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