Cleared Traditional

K230800 - XVISION-525

K230800 is an FDA 510(k) clearance for XVISION-525, manufactured by GEMSS HEALTHCARE CO., LTD.. The device is a Class 2 Radiology device with product code KPR cleared through the Traditional 510(k) pathway after a 224-day FDA review.

K230800 · GEMSS HEALTHCARE CO., LTD. · Radiology device
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Optimized for regulatory review, auditing and printing
Nov 2023
Decision
224d
Days
Class 2
Risk

K230800 is an FDA 510(k) clearance for the XVISION-525, HORIZON, HI-300, HI-500, SATURN-F PF32, SATURN-F PF40, SATURN-F .... Classified as System, X-ray, Stationary (product code KPR), Class II - Special Controls.

Submitted by GEMSS HEALTHCARE CO., LTD. (Paju-Si, KR). The FDA issued a Cleared decision on November 2, 2023 after a review of 224 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 GEMSS HEALTHCARE CO., LTD. devices

FDA 510(k) Submission Details - K230800

510(k) Number K230800 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 2023
Decision Date November 02, 2023
Days to Decision 224 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
117d slower than avg
Panel avg: 107d · This submission: 224d
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.

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All 192
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