Cleared Traditional

K233530 - EXSYS DEXi (EXSYS DEXi-D401S-FRM)

Also marketed or referenced as:
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)

K233530 is an FDA 510(k) clearance for EXSYS DEXi (EXSYS DEXi-D401S-FRM), manufactured by DRTECH Corporation. The device is a Class 2 Radiology device with product code KPR cleared through the Traditional 510(k) pathway after a 267-day FDA review.

K233530 · DRTECH Corporation · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2024
Decision
267d
Days
Class 2
Risk

K233530 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 July 26, 2024 after a review of 267 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 DRTECH Corporation devices

FDA 510(k) Submission Details - K233530

510(k) Number K233530 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 2023
Decision Date July 26, 2024
Days to Decision 267 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
160d slower than avg
Panel avg: 107d · This submission: 267d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KPR Device Classification - Class 2, Special Controls

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.

Regulatory Peers - KPR System, X-ray, Stationary

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