Cleared Abbreviated

K163528 - HITACHI Supria Whole-body X-ray CT Syst...

K163528 is the FDA 510(k) clearance for HITACHI Supria Whole-body X-ray CT Syst... by Hitachi Medical Systems America, Inc.. It is a Class 2 Radiology device (product code JAK) cleared through the Abbreviated 510(k) pathway after a 77-day FDA review.

K163528 · Hitachi Medical Systems America, Inc. · Radiology device
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Mar 2017
Decision
77d
Days
Class 2
Risk

K163528 is an FDA 510(k) clearance for the HITACHI Supria Whole-body X-ray CT System Phase 3. 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 March 3, 2017 after a review of 77 days - a notably fast clearance 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Hitachi Medical Systems America, Inc. devices

Submission Details

510(k) Number K163528 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 2016
Decision Date March 03, 2017
Days to Decision 77 days
Submission Type Abbreviated
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
30d faster than avg
Panel avg: 107d · This submission: 77d
Pathway characteristics
Standards-based clearance path.

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
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