Cleared Traditional

K041125 - MASEP SRRS GAMMA RAYS STEREOTACTIC RADIATION THERAPY SYSTEM FOR HEADS (MASEP GAMMA THERAPY SYSTEM)

K041125 is an FDA 510(k) clearance for MASEP SRRS GAMMA RAYS STEREOTACTIC RADI..., manufactured by Masep Med Science & Tech. Development (Shenzhen) C. The device is a Class 2 Radiology device with product code IWB cleared through the Traditional 510(k) pathway after a 244-day FDA review.

K041125 · Masep Med Science & Tech. Development (Shenzhen) C · Radiology device
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Dec 2004
Decision
244d
Days
Class 2
Risk

K041125 is an FDA 510(k) clearance for the MASEP SRRS GAMMA RAYS STEREOTACTIC RADIATION THERAPY SYSTEM FOR HEADS (MASEP .... Classified as System, Radiation Therapy, Radionuclide (product code IWB), Class II - Special Controls.

Submitted by Masep Med Science & Tech. Development (Shenzhen) C (Great Neck, US). The FDA issued a Cleared decision on December 30, 2004 after a review of 244 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5750 - 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.

FDA 510(k) Submission Details - K041125

510(k) Number K041125 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 2004
Decision Date December 30, 2004
Days to Decision 244 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
137d slower than avg
Panel avg: 107d · This submission: 244d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IWB Device Classification - Class 2, Special Controls

Product Code IWB System, Radiation Therapy, Radionuclide
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5750
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 - IWB System, Radiation Therapy, Radionuclide

All 41
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K041125 · MASEP SRRS GAMMA RAYS STEREOTACTIC RADIATION THERAPY SYSTEM FOR HEADS (MASEP GAMMA THERAPY SYSTEM)
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