Cleared Traditional

K101888 - SCENARIA WHOLE-BODY X-RAY CT SYSTEM

K101888 is the FDA 510(k) clearance for SCENARIA WHOLE-BODY X-RAY CT SYSTEM by Hitachi Medical Systems America, Inc.. It is a Class 2 Radiology device (product code JAK) cleared through the Traditional 510(k) pathway after a 275-day FDA review.

K101888 · Hitachi Medical Systems America, Inc. · Radiology device
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Apr 2011
Decision
275d
Days
Class 2
Risk

K101888 is an FDA 510(k) clearance for the SCENARIA WHOLE-BODY X-RAY CT SYSTEM. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Hitachi Medical Systems America, Inc. (Twinsburg, US). The FDA issued a Cleared decision on April 8, 2011 after a review of 275 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 Hitachi Medical Systems America, Inc. devices

Submission Details

510(k) Number K101888 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 2010
Decision Date April 08, 2011
Days to Decision 275 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
168d slower than avg
Panel avg: 107d · This submission: 275d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 593
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K101888.
SYNGO.CT VASCULAR ANALYSIS
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COMPUTED TOMOGRAPHY X-RAY SYSTEM
K102102 · VATECH Co., Ltd. · Mar 2011
SOMATOM DEFINITION AS
K103127 · Siemens Medical Solutions USA, Inc. · Mar 2011
DENTAL COMPUTED TOMOGRAPHY X-RAY SYSTEM
K102259 · VATECH Co., Ltd. · Feb 2011