Cleared Abbreviated

K040902 - HITACHI PRESTO

K040902 is an FDA 510(k) clearance for HITACHI PRESTO, manufactured by Hitachi Medical Systems America, Inc.. The device is a Class 2 Radiology device with product code JAK cleared through the Abbreviated 510(k) pathway after a 14-day FDA review.

K040902 · Hitachi Medical Systems America, Inc. · Radiology device
Download Printable Device Report (PDF)
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Apr 2004
Decision
14d
Days
Class 2
Risk

K040902 is an FDA 510(k) clearance for the HITACHI PRESTO. 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 21, 2004 after a review of 14 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

FDA 510(k) Submission Details - K040902

510(k) Number K040902 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 2004
Decision Date April 21, 2004
Days to Decision 14 days
Submission Type Abbreviated
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 107d · This submission: 14d
Pathway characteristics
Standards-based clearance path. Third-party reviewed.

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 Consultant

Intertek Testing Services
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