Q-Rad Radiographic System with Auto-Tracker Option— 510(k) K151924

Name: FDA 510(k) clearance K151924
Creator: U.S. Food and Drug Administration
Published: 2015-08-07

Substantially Equivalent

Quantum Medical Imaging Divison of Carestream

FDA 510(k) clearance K151924 for Q-Rad Radiographic System with Auto-Tracker Option, Substantially Equivalent on 2015-08-07. Applicant: Quantum Medical Imaging Divison of Carestream. Device class: 2.

Clearance details

Applicant: Quantum Medical Imaging Divison of Carestream
Product code: Code KPR
Device class: Class 2
Regulation: 21 CFR 892.1680
Advisory panel: Radiology
Date received: 2015-07-13
Decision date: 2015-08-07
Decision: Substantially Equivalent
Clearance type: Special
Location: Ronkonkoma, NY, 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

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.