Cleared Special

K023227 - USG 2000SA (FDA 510(k) Clearance)

Class II Radiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K023227 · Ultraguide , Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2002
Decision
25d
Days
Class 2
Risk

K023227 is an FDA 510(k) clearance for the USG 2000SA. Classified as Locator, Intracorporeal Device, Ultrasonic, Obstetric-gynecologic (product code HHJ), Class II - Special Controls.

Submitted by Ultraguide , Ltd. (Hasbrouck Heights, US). The FDA issued a Cleared decision on October 22, 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 884.2225 - 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.

View all Ultraguide , Ltd. devices

Submission Details

510(k) Number K023227 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2002
Decision Date October 22, 2002
Days to Decision 25 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
82d faster than avg
Panel avg: 107d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code HHJ Locator, Intracorporeal Device, Ultrasonic, Obstetric-gynecologic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.2225
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.