Cleared Traditional

K160143 - ClearVision ExamVue Flat Panel Detector

K160143 is an FDA 510(k) clearance for ClearVision ExamVue Flat Panel Detector, manufactured by Jpi Healthcare, Inc.. The device is a Class 2 Radiology device with product code MQB cleared through the Traditional 510(k) pathway after a 281-day FDA review.

K160143 · Jpi Healthcare, Inc. · Radiology device
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Oct 2016
Decision
281d
Days
Class 2
Risk

K160143 is an FDA 510(k) clearance for the ClearVision ExamVue Flat Panel Detector. Classified as Solid State X-ray Imager (flat Panel/digital Imager) (product code MQB), Class II - Special Controls.

Submitted by Jpi Healthcare, Inc. (Kuro 3-Dong, Kuro_Gu, KR). The FDA issued a Cleared decision on October 28, 2016 after a review of 281 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Jpi Healthcare, Inc. devices

FDA 510(k) Submission Details - K160143

510(k) Number K160143 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 2016
Decision Date October 28, 2016
Days to Decision 281 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
174d slower than avg
Panel avg: 107d · This submission: 281d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MQB Device Classification - Class 2, Special Controls

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 Consultant

Jpi Healthcare Solutions, Inc.
WILLIAM LITTLE

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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

All 422
Devices cleared under the same product code (MQB) and FDA review panel - the closest regulatory comparables to K160143.
Wireless Digital Flat Panel Detector
K161730 · Iray Technology (Shanghai) , Ltd. · Dec 2016
EVS 3643, EVS 3643G
K162552 · DRTECH Corporation · Dec 2016
CareView 750Cw/750C X-ray Flat Panel Detectors
K163019 · Careray Digital Medical System Co., Ltd. · Dec 2016
BSD3543 Digital Flat Panel X-ray Detector
K162487 · Bontech, Inc. · Oct 2016
1012WCC, 1012WGC
K162518 · Rayence Co., Ltd. · Oct 2016
1717WCC / 1717WGC
K162519 · Rayence Co., Ltd. · Oct 2016