Cleared Traditional

K955583 - VIFS

K955583 is an FDA 510(k) clearance for VIFS, manufactured by Konica Medical Corp.. The device is a Class 2 Radiology device with product code JAK cleared through the Traditional 510(k) pathway after a 161-day FDA review.

K955583 · Konica Medical Corp. · Radiology device
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May 1996
Decision
161d
Days
Class 2
Risk

K955583 is an FDA 510(k) clearance for the VIFS. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Konica Medical Corp. (Washington, US). The FDA issued a Cleared decision on May 14, 1996 after a review of 161 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1750 - 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 Konica Medical Corp. devices

FDA 510(k) Submission Details - K955583

510(k) Number K955583 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 1995
Decision Date May 14, 1996
Days to Decision 161 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
54d slower than avg
Panel avg: 107d · This submission: 161d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JAK Device Classification - Class 2, Special Controls

Product Code JAK System, X-ray, Tomography, Computed
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1750
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 - JAK System, X-ray, Tomography, Computed

All 696
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K955583.
SLS-CT
K960985 · Bio-Imaging Research, Inc. · Oct 1996
SELECT/SP
K961464 · Elscint, Inc. · Jul 1996
CT PROSPEED CT/I
K961055 · GE Medical Systems · Jun 1996
REAL-TIME RECONSTRUCTION SYSTEM MODEL TSXF-001A
K950972 · Toshiba America Medical Systems, In.C · Apr 1996
PULMO CT WITH REFERENCE DATABASE FOR THE SOMATOM PLUS AND PLUS 4 COMPUTED TOMOGRAPHY SYSTEMS
K960635 · Siemens Medical Solutions USA, Inc. · Apr 1996
SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-7000TX
K955255 · Shimadzu Medical Systems · Feb 1996