Cleared Traditional

K090504 - CSBP-001A BODY PERFUSION SYSTEM

K090504 is the FDA 510(k) clearance for CSBP-001A BODY PERFUSION SYSTEM by Toshibamedical Systems Corporation. It is a Class 2 Radiology device (product code JAK) cleared through the Traditional 510(k) pathway after a 7-day FDA review.

K090504 · Toshibamedical Systems Corporation · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2009
Decision
7d
Days
Class 2
Risk

K090504 is an FDA 510(k) clearance for the CSBP-001A BODY PERFUSION SYSTEM. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Toshibamedical Systems Corporation (Tustin, US). The FDA issued a Cleared decision on March 5, 2009 after a review of 7 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Toshibamedical Systems Corporation devices

Submission Details

510(k) Number K090504 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 2009
Decision Date March 05, 2009
Days to Decision 7 days
Submission Type Traditional
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
100d faster than avg
Panel avg: 107d · This submission: 7d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Regulatory Technology Services, LLC
MARK JOB

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 - JAK System, X-ray, Tomography, Computed

All 586
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K090504.
GUIDESHOT OPTION FOR CXR4 AND ECLOS CT SYSTEMS
K091103 · Hitachi Medical Systems America, Inc. · Jun 2009
PHILIPS MX 16 SLICE CT SYSTEM PHASE11, MODEL 9896 056 56511
K091195 · Philips Medical Systems (Cleveland), Inc. · May 2009
SYNGO DUAL ENERGY WITH EXTENDED FUNATIONALLY
K083524 · Siemens Medical Solutions USA, Inc. · Apr 2009
COLON VIEW, MODEL CSCV-001A
K090220 · Toshibamedical Systems Corporation · Feb 2009
PHILIPS MODEL MX 16 SLICE CT SYSTEM
K083498 · Philips Medical Systems (Cleveland), Inc. · Dec 2008
MODEL TSX-301B AQUILION CT SYSTEM
K083282 · Toshiba America Medical Systems, In.C · Dec 2008