Cleared Traditional

K945400 - HITACHI DYNAMIC 3D IMAGING SYSTEM

K945400 is the FDA 510(k) clearance for HITACHI DYNAMIC 3D IMAGING SYSTEM by Hitachi Medical Corp. of America. It is a Class 2 Radiology device (product code IZI) cleared through the Traditional 510(k) pathway after a 382-day FDA review.

K945400 · Hitachi Medical Corp. of America · Radiology device
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Nov 1995
Decision
382d
Days
Class 2
Risk

K945400 is an FDA 510(k) clearance for the HITACHI DYNAMIC 3D IMAGING SYSTEM,SF-VA100. Classified as System, X-ray, Angiographic (product code IZI), Class II - Special Controls.

Submitted by Hitachi Medical Corp. of America (Tarrytown, US). The FDA issued a Cleared decision on November 20, 1995 after a review of 382 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1600 - 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. Elevated predicate reliance profile. 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 Hitachi Medical Corp. of America devices

Submission Details

510(k) Number K945400 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 1994
Decision Date November 20, 1995
Days to Decision 382 days
Submission Type Traditional
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
275d slower than avg
Panel avg: 107d · This submission: 382d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IZI System, X-ray, Angiographic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1600
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 - IZI System, X-ray, Angiographic

All 100
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