Cleared Traditional

K250597 - REMEX Xcam6

K250597 is an FDA 510(k) clearance for REMEX Xcam6, manufactured by Remedi, Inc.. The device is a Class 2 Radiology device with product code IZL cleared through the Traditional 510(k) pathway after a 153-day FDA review.

K250597 · Remedi, Inc. · Radiology device
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Jul 2025
Decision
153d
Days
Class 2
Risk

K250597 is an FDA 510(k) clearance for the REMEX Xcam6. Classified as System, X-ray, Mobile (product code IZL), Class II - Special Controls.

Submitted by Remedi, Inc. (Seoul, KR). The FDA issued a Cleared decision on July 31, 2025 after a review of 153 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1720 - 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 Remedi, Inc. devices

FDA 510(k) Submission Details - K250597

510(k) Number K250597 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 2025
Decision Date July 31, 2025
Days to Decision 153 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
46d slower than avg
Panel avg: 107d · This submission: 153d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IZL Device Classification - Class 2, Special Controls

Product Code IZL System, X-ray, Mobile
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1720
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 - IZL System, X-ray, Mobile

All 132
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