Cleared Traditional

K974588 - INTRA-VIEW BILATERAL TRANSCRANIAL DOPPL...

K974588 is an FDA 510(k) clearance for INTRA-VIEW BILATERAL TRANSCRANIAL DOPPL..., manufactured by Rimed , Ltd.. The device is a Class 2 Radiology device with product code IYN cleared through the Traditional 510(k) pathway after a 241-day FDA review.

K974588 · Rimed , Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1998
Decision
241d
Days
Class 2
Risk

K974588 is an FDA 510(k) clearance for the INTRA-VIEW BILATERAL TRANSCRANIAL DOPPLER DEVICE, SMART-LITE PORTABLE BILATER.... 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. (Ginot Shomron 44853, IL). The FDA issued a Cleared decision on August 7, 1998 after a review of 241 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1550 - 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. Standard predicate reliance. 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 Rimed , Ltd. devices

FDA 510(k) Submission Details - K974588

510(k) Number K974588 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 1997
Decision Date August 07, 1998
Days to Decision 241 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
134d slower than avg
Panel avg: 107d · This submission: 241d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 923
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K974588.
COMBISON 530D WITH POWER DOPPLER MODE
K974813 · Medison America, Inc. · Sep 1998
AU5 ULTRASOUND IMAGING SYSTEM
K980468 · Biosound Esaote, Inc. · Aug 1998
SA8800 DIAGNOSTIC ULTRASOUND SYSTEM AND TRANSDUCERS,
K974269 · Medison America, Inc. · Aug 1998
HARMONIC IMAGING AND FLASH ECHO IMAGING FUNCTION FOR THE DIAGNOSTIC ULTRASOUND SYSTEM SSA-380A, POWERVISION 7000
K981397 · Toshiba America Medical Systems, In.C · Jul 1998
IMEX MEDICAL SYSTEMS, INC. IMEXLAB 9000
K973556 · Imex Medical Systems, Inc. · Apr 1998
SONOLINE ELEGRA DIAGNOSTIC ULTRASOUND SYSTEM WITH SUPERFICIAL MUSCULOSKELETAL IMAGING
K980557 · Siemens Medical Solutions USA, Inc. · Apr 1998