Cleared Special

K023227 - USG 2000SA

K023227 is an FDA 510(k) clearance for USG 2000SA, manufactured by Ultraguide , Ltd.. The device is a Class 2 Radiology device with product code HHJ cleared through the Special 510(k) pathway after a 25-day FDA review.

K023227 · Ultraguide , Ltd. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K023227

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
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.

HHJ Device Classification - Class 2, Special Controls

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.

K023227 · USG 2000SA
Download PDF FDA Summary Ultraguide , Ltd.