Cleared Traditional

K110590 - INTRABEAM NEEDLE APPLICATOR

K110590 is an FDA 510(k) clearance for INTRABEAM NEEDLE APPLICATOR, manufactured by Carl Zeiss Surgical GmbH. The device is a Class 2 Radiology device with product code JAD cleared through the Traditional 510(k) pathway after a 408-day FDA review.

K110590 · Carl Zeiss Surgical GmbH · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2012
Decision
408d
Days
Class 2
Risk

K110590 is an FDA 510(k) clearance for the INTRABEAM NEEDLE APPLICATOR. Classified as System, Therapeutic, X-ray (product code JAD), Class II - Special Controls.

Submitted by Carl Zeiss Surgical GmbH (Dublin, US). The FDA issued a Cleared decision on April 13, 2012 after a review of 408 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Radiology submissions.

FDA 510(k) Submission Details - K110590

510(k) Number K110590 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 2011
Decision Date April 13, 2012
Days to Decision 408 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
301d slower than avg
Panel avg: 107d · This submission: 408d
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 43
Devices cleared under the same product code (JAD) and FDA review panel - the closest regulatory comparables to K110590.
SENSUS HEALTHCARE SUPERFICIAL RADIOTHERAPY SYSTEM SRT-100
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INTRABEAM SYSTEM WITH INTRABEAM SPHERICAL APPLICATORS
K121653 · Carl Zeiss Meditec, Inc. · Dec 2012
AXXENT RADIATION SHIELD - RIGID
K111299 · Xoft, an Icad Company · Jul 2011
INTRABEAM SYSTEM WITH BALLOON APPLICATOR AND CBG SETS
K090584 · Carl Zeiss Surgical GmbH · Nov 2009
AXXENT BALLOON APPLICATOR, MODEL AB2034, AB2045, AB2056, AB2057E, AB2067E
K090914 · Xoft, Inc. · Jul 2009
K110590 · INTRABEAM NEEDLE APPLICATOR
Download PDF FDA Summary Carl Zeiss Surgical G…