Cleared Traditional

K130549 - INTRABEAM FLAT APPLICATOR, INTRABEAM SURFACE APPLICATOR

K130549 is an FDA 510(k) clearance for INTRABEAM FLAT APPLICATOR, manufactured by Carl Zeiss Meditec, Inc.. The device is a Class 2 Radiology device with product code JAD cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K130549 · Carl Zeiss Meditec, Inc. · Radiology device
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Jun 2013
Decision
114d
Days
Class 2
Risk

K130549 is an FDA 510(k) clearance for the INTRABEAM FLAT APPLICATOR, INTRABEAM SURFACE APPLICATOR. Classified as System, Therapeutic, X-ray (product code JAD), Class II - Special Controls.

Submitted by Carl Zeiss Meditec, Inc. (Dublin, US). The FDA issued a Cleared decision on June 26, 2013 after a review of 114 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5900 - 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 Carl Zeiss Meditec, Inc. devices

FDA 510(k) Submission Details - K130549

510(k) Number K130549 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 2013
Decision Date June 26, 2013
Days to Decision 114 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
7d slower than avg
Panel avg: 107d · This submission: 114d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JAD Device Classification - Class 2, Special Controls

Product Code JAD System, Therapeutic, X-ray
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5900
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 - JAD System, Therapeutic, X-ray

All 40
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