Cleared Traditional

K061625 - AUTOBONE2

K061625 is the FDA 510(k) clearance for AUTOBONE2 by Ge Healthcare. It is a Class 2 Radiology device (product code JAK) cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K061625 · Ge Healthcare · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2006
Decision
14d
Days
Class 2
Risk

K061625 is an FDA 510(k) clearance for the AUTOBONE2. 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 June 26, 2006 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 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 K061625 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 2006
Decision Date June 26, 2006
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 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
DANIEL W LEHTONEN

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 604
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K061625.
SYNGO DUAL ENERGY
K062351 · Siemens Medical Solutions USA, Inc. · Oct 2006
MODIFICATION TO SYNGO INSPACE 4D
K062673 · Siemens AG Medical Solutions · Sep 2006
LIGHTSPEED 7.1 CT SCANNER SYSTEM
K061817 · Ge Medical Systems, LLC · Jul 2006
BRILLIANCE VOLUME
K060937 · Philips Medical Systems (Cleveland), Inc. · Jun 2006
CARDIQ FUSION
K061370 · Ge Healthcare · May 2006
TSX-201A, AQUILION LB CT SCANNER WITH RESPIRATORY GATING
K061187 · Toshiba America Medical Systems, In.C · May 2006