Cleared Traditional

IVR MASTER (K945389) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K945389 · Shimadzu Corp. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1995
Decision
96d
Days
Class 2
Risk

K945389 is an FDA 510(k) clearance for the IVR MASTER. Classified as System, Image Processing, Radiological within the LLZ classification (a category encompassing advanced image processing and PACS-adjacent software), Class II - Special Controls.

Submitted by Shimadzu Corp. (Torrance, US). The FDA issued a Cleared decision on February 7, 1995 after a review of 96 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2050 - 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: Incremental AI imaging tool. Moderate equivalence dependency. Overall, this clearance reflects a predicate-aligned approval typical of modern AI radiology extensions - not a novel clinical breakthrough, but a validated iteration within an established regulatory category.

View all Shimadzu Corp. devices

Submission Details

510(k) Number K945389 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 1994
Decision Date February 07, 1995
Days to Decision 96 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
11d faster than avg
Panel avg: 107d · This submission: 96d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LLZ System, Image Processing, Radiological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2050
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 - LLZ System, Image Processing, Radiological

All 730
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K945389.
PICKER MR WORKSTATIONS (VISTAR,MONTAGE AND ONCALL)
K961637 · Philips Medical Systems (Cleveland), Inc. · Jul 1996
DIGISCAN 2 PLUS
K955457 · Siemens Medical Solutions USA, Inc. · Jun 1996
HP ECHO IMAGE MANAGEMENT SYSTEM
K954668 · Hewlett-Packard Co. · Nov 1995
SIENET DIAGNOSTIC REPORTING CONSOLE VA02 UPGRADE
K935694 · Siemens Medical Solutions USA, Inc. · Mar 1994
DU PONT LINX HD-25 LASR IMAGER
K923042 · E.I. Dupont DE Nemours & Co., Inc. · Nov 1992
KODAK EKTASCAN IMAGELINK QUALITY CONTROL WORKSTATI
K923270 · Eastman Kodak Company · Sep 1992