Cleared Traditional

K091734 - SONIC SHOT GX

K091734 is an FDA 510(k) clearance for SONIC SHOT GX, manufactured by Nemoto Kyorindo Co., Ltd.. The device is a Class 2 Radiology device with product code IZQ cleared through the Traditional 510(k) pathway after a 344-day FDA review.

K091734 · Nemoto Kyorindo Co., Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2010
Decision
344d
Days
Class 2
Risk

K091734 is an FDA 510(k) clearance for the SONIC SHOT GX. Classified as Injector, Contrast Medium, Automatic (product code IZQ), Class II - Special Controls.

Submitted by Nemoto Kyorindo Co., Ltd. (Kawaguchi-Shi, Saitama, JP). The FDA issued a Cleared decision on May 21, 2010 after a review of 344 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 870.1650 - 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Nemoto Kyorindo Co., Ltd. devices

FDA 510(k) Submission Details - K091734

510(k) Number K091734 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 2009
Decision Date May 21, 2010
Days to Decision 344 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
237d slower than avg
Panel avg: 107d · This submission: 344d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IZQ Device Classification - Class 2, Special Controls

Product Code IZQ Injector, Contrast Medium, Automatic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1650
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 - IZQ Injector, Contrast Medium, Automatic

All 14
Devices cleared under the same product code (IZQ) and FDA review panel - the closest regulatory comparables to K091734.
ulrichINJECT CT motion
K210541 · Ulrich GmbH & Co. KG · Aug 2021
ulrichINJECT CT Motion
K192872 · Ulrich GmbH & Co. KG · Jul 2020
ulrichINJECT CT motion
K171392 · Ulrich GmbH & Co. KG · Nov 2017
EMPOWERMR INJECTOR SYSTEM, MODEL 9730
K062449 · E-Z-Em, Inc. · Apr 2007
MEDRAD STELLANT CT INJECTOR SYSTEM WITH XDS ACCESSORY
K063090 · Medrad, Inc. · Mar 2007
EMPOWERCTA INJECTOR SYSTEM, MODELS 9930 & 9910 & 9825
K031571 · E-Z-Em, Inc. · Jun 2003