Cleared Traditional

K082830 - INFX-8000H

K082830 is the FDA 510(k) clearance for INFX-8000H by Toshiba America Medical Systems, In.C. It is a Class 2 Radiology device (product code JAA) cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K082830 · Toshiba America Medical Systems, In.C · Radiology device
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Oct 2008
Decision
14d
Days
Class 2
Risk

K082830 is an FDA 510(k) clearance for the INFX-8000H, INFINIX-I. Classified as System, X-ray, Fluoroscopic, Image-intensified (product code JAA), Class II - Special Controls.

Submitted by Toshiba America Medical Systems, In.C (Tustin, US). The FDA issued a Cleared decision on October 10, 2008 after a review of 14 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1650 - 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 Toshiba America Medical Systems, In.C devices

Submission Details

510(k) Number K082830 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2008
Decision Date October 10, 2008
Days to Decision 14 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
93d faster than avg
Panel avg: 107d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code JAA System, X-ray, Fluoroscopic, Image-intensified
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1650
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 - JAA System, X-ray, Fluoroscopic, Image-intensified

All 135
Devices cleared under the same product code (JAA) and FDA review panel - the closest regulatory comparables to K082830.
GENESIS
K122768 · Dornier Medtech America, Inc. · Jan 2013
LUMINOS AGILE
K111292 · Siemens Medical Solutions USA, Inc. · Jun 2011
UROSKOP OMNIA
K101491 · Siemens Medical Solutions USA, Inc. · Jun 2010
INFX-8000C (INFINIX CC-I AND VC-I)
K081621 · Toshiba America Medical Systems, In.C · Jun 2008
SMITH & NEPHEW CDS SYSTEM
K081491 · Smith & Nephew, Inc. · Jun 2008
INFX-8000V, INFINIX-CFI AND INFINIX VFI
K081582 · Toshiba America Medical Systems, In.C · Jun 2008