Cleared Traditional

K991231 - HITACHI VERSIFLEX

K991231 is the FDA 510(k) clearance for HITACHI VERSIFLEX by Hitachi Medical Systems America, Inc.. It is a Class 2 Radiology device (product code IZI) cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K991231 · Hitachi Medical Systems America, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1999
Decision
42d
Days
Class 2
Risk

K991231 is an FDA 510(k) clearance for the HITACHI VERSIFLEX. Classified as System, X-ray, Angiographic (product code IZI), Class II - Special Controls.

Submitted by Hitachi Medical Systems America, Inc. (Rockville, US). The FDA issued a Cleared decision on May 24, 1999 after a review of 42 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Hitachi Medical Systems America, Inc. devices

Submission Details

510(k) Number K991231 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 1999
Decision Date May 24, 1999
Days to Decision 42 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
65d faster than avg
Panel avg: 107d · This submission: 42d
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 99
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