Cleared Special

K051055 - INTRABEAM SYSTEM

K051055 is an FDA 510(k) clearance for INTRABEAM SYSTEM, manufactured by Carl Zeiss Surgical GmbH. The device is a Class 2 Radiology device with product code JAD cleared through the Special 510(k) pathway after a 27-day FDA review.

K051055 · Carl Zeiss Surgical GmbH · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2005
Decision
27d
Days
Class 2
Risk

K051055 is an FDA 510(k) clearance for the INTRABEAM SYSTEM. Classified as System, Therapeutic, X-ray (product code JAD), Class II - Special Controls.

Submitted by Carl Zeiss Surgical GmbH (North Attleboro, US). The FDA issued a Cleared decision on May 23, 2005 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5900 - the FDA radiology and imaging software oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K051055

510(k) Number K051055 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 2005
Decision Date May 23, 2005
Days to Decision 27 days
Submission Type Special
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
80d faster than avg
Panel avg: 107d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

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 K051055.
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K051055 · INTRABEAM SYSTEM
Download PDF FDA Summary Carl Zeiss Surgical G…