Cleared Traditional

K152244 - RADspeed Pro

K152244 is an FDA 510(k) clearance for RADspeed Pro, manufactured by Shimadzu Corporation. The device is a Class 2 Radiology device with product code KPR cleared through the Traditional 510(k) pathway after a 315-day FDA review.

K152244 · Shimadzu Corporation · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2016
Decision
315d
Days
Class 2
Risk

K152244 is an FDA 510(k) clearance for the RADspeed Pro. Classified as System, X-ray, Stationary (product code KPR), Class II - Special Controls.

Submitted by Shimadzu Corporation (Kyoto, JP). The FDA issued a Cleared decision on June 20, 2016 after a review of 315 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1680 - 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. Elevated predicate reliance profile. 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 Shimadzu Corporation devices

FDA 510(k) Submission Details - K152244

510(k) Number K152244 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 2015
Decision Date June 20, 2016
Days to Decision 315 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
208d slower than avg
Panel avg: 107d · This submission: 315d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KPR Device Classification - Class 2, Special Controls

Product Code KPR System, X-ray, Stationary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1680
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

Shimadzu Medical Systems
Toshio Kadowaki

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - KPR System, X-ray, Stationary

All 264
Devices cleared under the same product code (KPR) and FDA review panel - the closest regulatory comparables to K152244.
ArtPix Mobile EZ2GO
K162224 · Cmt Medical Technologies, Ltd. · Sep 2016
FDR Visionary Suite
K152294 · Shimadzu Corporation · Jul 2016
GC85A
K160997 · Samsung Electronics Co., Ltd. · Jul 2016
Visaris Vision® (Vision C, Vision U. Vision V, Vision X)
K160620 · Visaris D.O.O. Belgrade · Mar 2016
Amrad Medical OTS Digital Radiography System, Amrad Medical DFMTS Digital Radiography SystemAmrad Medical FRS Digital Radiography System,
K153119 · Summit Industries, LLC · Mar 2016
OTC12D AUTO RADIOGRAPHIC SYSTEM
K152767 · Del Medical, Inc. · Dec 2015