UNIVERSAL DIGITAL INTERFACE (UDI) 1717— 510(k) K112527

Name: FDA 510(k) clearance K112527
Creator: U.S. Food and Drug Administration
Published: 2012-05-22

Substantially Equivalent

Meridian Medical Systems, LLC

FDA 510(k) clearance K112527 for UNIVERSAL DIGITAL INTERFACE (UDI) 1717, Substantially Equivalent on 2012-05-22. Applicant: Meridian Medical Systems, LLC. Device class: 2.

Clearance details

Applicant: Meridian Medical Systems, LLC
Product code: Code MQB
Device class: Class 2
Regulation: 21 CFR 892.1680
Advisory panel: Radiology
Date received: 2011-08-31
Decision date: 2012-05-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Aurora, OH, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MQB

view all

K253800 — 0909FCE, 0909FCE-HS2026-07-31
K260820 — VIVIX-S 4386W (FXRD-4386WA)2026-06-18
K252996 — Universal 1417PI2026-06-12
K252911 — Lux HD 2530 detector (Lux HD 2530)2025-10-09
K250211 — Yushan X-Ray Flat Panel Detector2025-07-22

More clearances from Meridian Medical Systems, LLC

view all

K162687 — Paragon 22016-10-21
K143232 — Universal Digital Interface 2W, UDI 2W2015-01-30
K140251 — UNIVERSAL DIGITAL INTERFACE 2, UDI 22014-10-22
K111305 — UNIVERSAL DIGITAL INTERFACE WIRELESS - UDI 1417W2012-01-31
K103599 — UNIVERSAL DIGITAL INTERFACE (UDI) 17172011-04-27

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