Cleared Special

CareView 1800Le (K193173) - FDA 510(k) Clearance

Class II Radiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K193173 · Careray Digital Medical System Co., Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2019
Decision
25d
Days
Class 2
Risk

K193173 is an FDA 510(k) clearance for the CareView 1800Le. Classified as Solid State X-ray Imager (flat Panel/digital Imager) (product code MQB), Class II - Special Controls.

Submitted by Careray Digital Medical System Co., Ltd. (Suzhou, CN). The FDA issued a Cleared decision on December 13, 2019 after a review of 25 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Careray Digital Medical System Co., Ltd. devices

Submission Details

510(k) Number K193173 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 2019
Decision Date December 13, 2019
Days to Decision 25 days
Submission Type Special
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
82d faster than avg
Panel avg: 107d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

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 149
Devices cleared under the same product code (MQB) and FDA review panel - the closest regulatory comparables to K193173.
E-COM DR-2000 DR
K193644 · Livermoretech, Inc. · Feb 2020
HAD1717MC
K200018 · H&Abyz · Jan 2020
Nexus DR Digital X-Ray Imaging System (with vSharp)
K193238 · Varex Imaging Corporation · Dec 2019
EVS 4343W / EVS 4343WG / EVS 4343WP / EVS 3643W / EVS 3643WG / EVS 3643WP
K193017 · DRTECH Corporation · Nov 2019
EXPD 4343P, EXPD 3643P
K193031 · DRTECH Corporation · Nov 2019
FDR D-EVO III flat panel detector system
K192932 · Fujifilm Corporation · Nov 2019