Cleared Special

K022354 - ULTRAGUIDE CTG 2000SA

K022354 is an FDA 510(k) clearance for ULTRAGUIDE CTG 2000SA, manufactured by Ultraguide , Ltd.. The device is a Class 2 Radiology device with product code JAK cleared through the Special 510(k) pathway after a 25-day FDA review.

K022354 · Ultraguide , Ltd. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2002
Decision
25d
Days
Class 2
Risk

K022354 is an FDA 510(k) clearance for the ULTRAGUIDE CTG 2000SA. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Ultraguide , Ltd. (Hasbrouck Heights, US). The FDA issued a Cleared decision on August 13, 2002 after a review of 25 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1750 - 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 - K022354

510(k) Number K022354 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 2002
Decision Date August 13, 2002
Days to Decision 25 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
82d faster than avg
Panel avg: 107d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

JAK Device Classification - Class 2, Special Controls

Product Code JAK System, X-ray, Tomography, Computed
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1750
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 - JAK System, X-ray, Tomography, Computed

All 787
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K022354 · ULTRAGUIDE CTG 2000SA
Download PDF FDA Summary Ultraguide , Ltd.