Cleared Traditional

K183245 - Carestream DRX-1 System with DRX Plus 2...

K183245 is the FDA 510(k) clearance for Carestream DRX-1 System with DRX Plus 2... by Carestream Health, Inc.. It is a Class 2 Radiology device (product code MQB) cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K183245 · Carestream Health, Inc. · Radiology device
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Feb 2019
Decision
79d
Days
Class 2
Risk

K183245 is an FDA 510(k) clearance for the Carestream DRX-1 System with DRX Plus 2530 Detectors. Classified as Solid State X-ray Imager (flat Panel/digital Imager) (product code MQB), Class II - Special Controls.

Submitted by Carestream Health, Inc. (Rochester, US). The FDA issued a Cleared decision on February 8, 2019 after a review of 79 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1680 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Carestream Health, Inc. devices

Submission Details

510(k) Number K183245 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2018
Decision Date February 08, 2019
Days to Decision 79 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 107d · This submission: 79d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MQB Solid State X-ray Imager (flat Panel/digital Imager)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1680
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - MQB Solid State X-ray Imager (flat Panel/digital Imager)

All 218
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