Cleared Traditional

Xcam (K192700) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K192700 · Hdx Will Corp. · Radiology device
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Dec 2019
Decision
92d
Days
Class 2
Risk

K192700 is an FDA 510(k) clearance for the Xcam. Classified as Unit, X-ray, Extraoral With Timer (product code EHD), Class II - Special Controls.

Submitted by Hdx Will Corp. (Cheongju-Si, KR). The FDA issued a Cleared decision on December 27, 2019 after a review of 92 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 872.1800 - 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 Hdx Will Corp. devices

Submission Details

510(k) Number K192700 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2019
Decision Date December 27, 2019
Days to Decision 92 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
15d faster than avg
Panel avg: 107d · This submission: 92d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EHD Unit, X-ray, Extraoral With Timer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.1800
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 - EHD Unit, X-ray, Extraoral With Timer

All 49
Devices cleared under the same product code (EHD) and FDA review panel - the closest regulatory comparables to K192700.
Portray
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EzRay Air Portable (Model: VEX-P300)
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EZER, Portable X-ray System
K190935 · Livermoretech, Inc. · Dec 2019
MINE
K180671 · Rht Co., Ltd. · Jun 2019
Star-X, Intraoral X-ray System
K190357 · Hdx Will Corp. · Mar 2019