Cleared Special

K040370 - WBR-FHR, WBR-FWB

K040370 is an FDA 510(k) clearance for WBR-FHR, manufactured by Ultraspect , Ltd.. The device is a Class 2 Radiology device with product code KPS cleared through the Special 510(k) pathway after a 27-day FDA review.

K040370 · Ultraspect , Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2004
Decision
27d
Days
Class 2
Risk

K040370 is an FDA 510(k) clearance for the WBR-FHR, WBR-FWB. Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by Ultraspect , Ltd. (Haifa, IL). The FDA issued a Cleared decision on March 11, 2004 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1200 - 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 Ultraspect , Ltd. devices

FDA 510(k) Submission Details - K040370

510(k) Number K040370 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 2004
Decision Date March 11, 2004
Days to Decision 27 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
80d faster than avg
Panel avg: 107d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

KPS Device Classification - Class 2, Special Controls

Product Code KPS System, Tomography, Computed, Emission
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1200
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 - KPS System, Tomography, Computed, Emission

All 315
Devices cleared under the same product code (KPS) and FDA review panel - the closest regulatory comparables to K040370.
SYNTEGRA
K041182 · Adac Laboratories · May 2004
SIEMENS ENHANCED IMAGING SYSTEM
K041166 · Siemens Medical Solutions USA, Inc. · May 2004
MODIFICATION TO GE DISCOVERY LS SYSTEM
K040172 · GE Medical Systems · Apr 2004
AUTOQUANT PLUS
K040326 · Adac Laboratories · Feb 2004
MYOLIGHT
K033874 · Ge Medical Systems F.I. Haifa · Dec 2003
ALLEGRO IMAGING SYSTEM
K033782 · Philips Medical Systems (Cleveland), Inc. · Dec 2003