Cleared Traditional

K031631 - STEREOTACTIC BODY FRAME, MODEL COD. 70-1A

K031631 is an FDA 510(k) clearance for STEREOTACTIC BODY FRAME, manufactured by 3D Line USA, Inc.. The device is a Class 2 Radiology device with product code IYE cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K031631 · 3D Line USA, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2003
Decision
52d
Days
Class 2
Risk

K031631 is an FDA 510(k) clearance for the STEREOTACTIC BODY FRAME, MODEL COD. 70-1A. Classified as Accelerator, Linear, Medical (product code IYE), Class II - Special Controls.

Submitted by 3D Line USA, Inc. (Owings Mills, US). The FDA issued a Cleared decision on July 18, 2003 after a review of 52 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5050 - 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 3D Line USA, Inc. devices

FDA 510(k) Submission Details - K031631

510(k) Number K031631 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 2003
Decision Date July 18, 2003
Days to Decision 52 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 107d · This submission: 52d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IYE Device Classification - Class 2, Special Controls

Product Code IYE Accelerator, Linear, Medical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5050
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 Peers - IYE Accelerator, Linear, Medical

All 477
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