Cleared Special

K062578 - DIGI-LITE TCD DEVICE

K062578 is an FDA 510(k) clearance for DIGI-LITE TCD DEVICE, manufactured by Rimed , Ltd.. The device is a Class 2 Radiology device with product code IYN cleared through the Special 510(k) pathway after a 18-day FDA review.

K062578 · Rimed , Ltd. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2006
Decision
18d
Days
Class 2
Risk

K062578 is an FDA 510(k) clearance for the DIGI-LITE TCD DEVICE. Classified as System, Imaging, Pulsed Doppler, Ultrasonic within the IYN classification (a category covering pulsed Doppler and ultrasound imaging systems), Class II - Special Controls.

Submitted by Rimed , Ltd. (Kfar Saba, IL). The FDA issued a Cleared decision on September 18, 2006 after a review of 18 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1550 - 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 - K062578

510(k) Number K062578 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 2006
Decision Date September 18, 2006
Days to Decision 18 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
89d faster than avg
Panel avg: 107d · This submission: 18d
Pathway characteristics
Modification to existing cleared device.

IYN Device Classification - Class 2, Special Controls

Product Code IYN System, Imaging, Pulsed Doppler, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1550
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 - IYN System, Imaging, Pulsed Doppler, Ultrasonic

All 1165
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K062578.
MODIFICATION TO ACUSON ANTARES ULTRASOUND SYSTEM
K063138 · Siemens Medical Solutions USA, Inc. · Nov 2006
SONARA
K060421 · Viasys Healthcare, Inc. · Nov 2006
APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA-790A, VERSION 1.0
K063130 · Toshibamedical Systems Corporation · Nov 2006
HD11 DIAGNOSTIC ULTRASOUND SYSTEM
K062247 · Philips Ultrasound, Inc. · Aug 2006
SIEMENS ACUSON X500 ULTRASOUND SYSTEM
K061980 · Siemens Medical Solutions USA, Inc. · Aug 2006
MEDCHANNEL HTS SYSTEM
K061831 · Medchannel, LLC · Aug 2006