Cleared Special

K071378 - MODIFICATION TO EMPOWER CT/CTA INJECTOR SYSTEM, MODELS 9800/9900 PRODUCT SERIES

K071378 is an FDA 510(k) clearance for MODIFICATION TO EMPOWER CT/CTA INJECTOR..., manufactured by E-Z-Em, Inc.. The device is a Class 2 Radiology device with product code JAK cleared through the Special 510(k) pathway after a 27-day FDA review.

K071378 · E-Z-Em, Inc. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2007
Decision
27d
Days
Class 2
Risk

K071378 is an FDA 510(k) clearance for the MODIFICATION TO EMPOWER CT/CTA INJECTOR SYSTEM, MODELS 9800/9900 PRODUCT SERIES. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by E-Z-Em, Inc. (Westbury, US). The FDA issued a Cleared decision on June 13, 2007 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1750 - 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 - K071378

510(k) Number K071378 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 2007
Decision Date June 13, 2007
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.

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 826
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K071378.
ECLOS COMPUTED TOMOGRAPHY X-RAY SYSTEM
K071806 · Hitachi Medical Systems America, Inc. · Aug 2007
MODIFICATION TO NEUVIZ DUAL MULTI-SLICE CT SCANNER SYSTEM
K071308 · Neusoft Medical Systems Co., Ltd. · Aug 2007
INSPACE 4D SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY
K071513 · Siemens Medical Solutions · Jun 2007
SYNGO CT ONCOLOGY SOFTWARE PACKAGE
K071310 · Siemens AG · Jun 2007
DENTAL DIGITAL PANORAMIC/3D IMAGING SYSTEM
K070658 · E-Woo Technology · Apr 2007
PET VCAR
K063324 · Ge Healthcare · Mar 2007
K071378 · MODIFICATION TO EMPOWER CT/CTA INJECTOR SYSTEM, MODELS 9800/9900 PRODUCT SERIES
Download PDF FDA Summary E-Z-Em, Inc.