AcuityUDR— 510(k) K231995

Name: FDA 510(k) clearance K231995
Creator: U.S. Food and Drug Administration
Published: 2023-10-25

Substantially Equivalent

Radmedix, LLC

FDA 510(k) clearance K231995 for AcuityUDR, Substantially Equivalent on 2023-10-25. Applicant: Radmedix, LLC. Device class: 2.

Clearance details

Applicant: Radmedix, LLC
Product code: Code KPR
Device class: Class 2
Regulation: 21 CFR 892.1680
Advisory panel: Radiology
Date received: 2023-07-05
Decision date: 2023-10-25
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Dayton, OH, US

Download summary PDF View on FDA.gov ↗

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K260481 — GC85A2026-08-27
K260482 — DRE Duo2026-06-15
K253446 — AeroDR TX c022026-04-10

More clearances from Radmedix, LLC

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K231709 — AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717G42023-07-12
K210919 — AcuityDRe2021-04-30
K201058 — Accuvue+2020-05-06
K200726 — AcuityPDR2020-04-13
K193360 — Acuity SDR Standard, Acuity SDR Plus, Acuity FDR Standard2020-01-02

Adverse events under product code KPR

product code KPR

Other: 6
Total: 6

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.