ArcherQA (V1.0)— 510(k) K231273

Name: FDA 510(k) clearance K231273
Creator: U.S. Food and Drug Administration
Published: 2024-01-05

Substantially Equivalent

Wisdom Technologies., Inc.

FDA 510(k) clearance K231273 for ArcherQA (V1.0), Substantially Equivalent on 2024-01-05. Applicant: Wisdom Technologies., Inc.. Device class: 2.

Clearance details

Applicant: Wisdom Technologies., Inc.
Product code: Code IYE
Device class: Class 2
Regulation: 21 CFR 892.5050
Advisory panel: Radiology
Date received: 2023-05-02
Decision date: 2024-01-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hefei, CN

Download summary PDF View on FDA.gov ↗

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K232928 — DeepContour (V1.0)2024-05-07

Adverse events under product code IYE

product code IYE

Malfunction: 455
Other: 3
Total: 458

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 →

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