Cleared Traditional

STARSPEED SERIES CT SCANNER SYSTEMS (K052855) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K052855 · Ge Healthcare · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2005
Decision
17d
Days
Class 2
Risk

K052855 is an FDA 510(k) clearance for the STARSPEED SERIES CT SCANNER SYSTEMS. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Ge Healthcare (Waukesha, US). The FDA issued a Cleared decision on October 28, 2005 after a review of 17 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 Ge Healthcare devices

Submission Details

510(k) Number K052855 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 2005
Decision Date October 28, 2005
Days to Decision 17 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
90d faster than avg
Panel avg: 107d · This submission: 17d
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

Tuv Rheinland of North America, Inc.
TAMAS BORSAI

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 384
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K052855.
CARDIQ FUSION
K061370 · Ge Healthcare · May 2006
ADVANCE VESSEL ANALYSIS II
K060779 · Ge Healthcare · Apr 2006
CT PERFUSION 4
K052839 · Ge Healthcare · Mar 2006
SOMATOM RESPIRATORY GATING
K043086 · Siemens Medical Solutions USA, Inc. · Dec 2004
SOMATOM CARE CONTRAST CT
K043087 · Siemens Medical Solutions USA, Inc. · Dec 2004
BRILLIANCE CT, PRIVATE PRACTICE CV CONFIGURATION, CT SCANNER
K042293 · Philips Medical Systems (Cleveland), Inc. · Sep 2004