Cleared Traditional

K201591 - Flat Panel Detector

K201591 is the FDA 510(k) clearance for Flat Panel Detector by Ka Imaging, Inc.. It is a Class 2 Radiology device (product code MQB) cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K201591 · Ka Imaging, Inc. · Radiology device
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Sep 2020
Decision
83d
Days
Class 2
Risk

K201591 is an FDA 510(k) clearance for the Flat Panel Detector. Classified as Solid State X-ray Imager (flat Panel/digital Imager) (product code MQB), Class II - Special Controls.

Submitted by Ka Imaging, Inc. (Waterloo, CA). The FDA issued a Cleared decision on September 3, 2020 after a review of 83 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 Ka Imaging, Inc. devices

Submission Details

510(k) Number K201591 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 2020
Decision Date September 03, 2020
Days to Decision 83 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
24d faster than avg
Panel avg: 107d · This submission: 83d
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
Devices cleared under the same product code (MQB) and FDA review panel - the closest regulatory comparables to K201591.
1212FCA
K202722 · Rayence Co., Ltd. · Oct 2020
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1717SCV, 1717SGV
K201796 · Rayence Co., Ltd. · Jul 2020
Edge Air(1417) Digital Flat Panel X-ray Detector
K201503 · Osko, Inc. · Jun 2020