Cleared Traditional

K220579 - Hybrid C70

K220579 is an FDA 510(k) clearance for Hybrid C70, manufactured by Digimed Co., Ltd.. The device is a Class 2 Radiology device with product code EHD cleared through the Traditional 510(k) pathway after a 192-day FDA review.

K220579 · Digimed Co., Ltd. · Radiology device
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Sep 2022
Decision
192d
Days
Class 2
Risk

K220579 is an FDA 510(k) clearance for the Hybrid C70. Classified as Unit, X-ray, Extraoral With Timer (product code EHD), Class II - Special Controls.

Submitted by Digimed Co., Ltd. (Seul, KR). The FDA issued a Cleared decision on September 1, 2022 after a review of 192 days - an extended review cycle.

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 Digimed Co., Ltd. devices

FDA 510(k) Submission Details - K220579

510(k) Number K220579 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 2022
Decision Date September 01, 2022
Days to Decision 192 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
85d slower than avg
Panel avg: 107d · This submission: 192d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EHD Device Classification - Class 2, Special Controls

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

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