Cleared Special

K242847 - EXSYS DEXi (EXSYS DEXi-D401S-FRM) (FDA 510(k) Clearance)

Also includes:
EXSYS DEXi (EXSYS DEXi-A401S-FRM) EXSYS DEXi (EXSYS DEXi-D402S-FRM) EXSYS DEXi (EXSYS DEXi-A402S-FRM) EXSYS DEXi (EXSYS DEXi-D401P-FRM) EXSYS DEXi (EXSYS DEXi-A401P-FRM) EXSYS DEXi (EXSYS DEXi-D402P-FRM) EXSYS DEXi (EXSYS DEXi-A402P-FRM) EXSYS DEXi (EXSYS DEXi-D503T-FRM) EXSYS DEXi (EXSYS DEXi-A503T-FRM) EXSYS DEXi (EXSYS DEXi-D401S-FRA) EXSYS DEXi (EXSYS DEXi-D402S-FRA) EXSYS DEXi (EXSYS DEXi-D401P-FRA) EXSYS DEXi (EXSYS DEXi-D402P-FRA)

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

K242847 · DRTECH Corporation · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2024
Decision
33d
Days
Class 2
Risk

K242847 is an FDA 510(k) clearance for the EXSYS DEXi (EXSYS DEXi-D401S-FRM). Classified as System, X-ray, Stationary (product code KPR), Class II - Special Controls.

Submitted by DRTECH Corporation (Seongnam-Si, KR). The FDA issued a Cleared decision on October 23, 2024 after a review of 33 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 DRTECH Corporation devices

Submission Details

510(k) Number K242847 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 2024
Decision Date October 23, 2024
Days to Decision 33 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
74d faster than avg
Panel avg: 107d · This submission: 33d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code KPR System, X-ray, Stationary
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.

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