Cleared Traditional

K141900 - SAGIPLAN

K141900 is an FDA 510(k) clearance for SAGIPLAN, manufactured by Eckert & Ziegler Bebig GmbH. The device is a Class 2 Radiology device with product code MUJ cleared through the Traditional 510(k) pathway after a 310-day FDA review.

K141900 · Eckert & Ziegler Bebig GmbH · Radiology device
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May 2015
Decision
310d
Days
Class 2
Risk

K141900 is an FDA 510(k) clearance for the SAGIPLAN, SAGIPLAN PROSTATE MODULE ADD ON, SAGIPLAN INCLUDING PROSTATE MODULE. Classified as System, Planning, Radiation Therapy Treatment (product code MUJ), Class II - Special Controls.

Submitted by Eckert & Ziegler Bebig GmbH (Veenendaal, NL). The FDA issued a Cleared decision on May 20, 2015 after a review of 310 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5050 - 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. Elevated predicate reliance profile. 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 Eckert & Ziegler Bebig GmbH devices

FDA 510(k) Submission Details - K141900

510(k) Number K141900 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 2014
Decision Date May 20, 2015
Days to Decision 310 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
203d slower than avg
Panel avg: 107d · This submission: 310d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MUJ Device Classification - Class 2, Special Controls

Product Code MUJ System, Planning, Radiation Therapy Treatment
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5050
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 - MUJ System, Planning, Radiation Therapy Treatment

All 161
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