Cleared Traditional

K040773 - PELVIS BELLYBOARD PLUS PATIENT POSITION...

K040773 is the FDA 510(k) clearance for PELVIS BELLYBOARD PLUS PATIENT POSITION... by Bionix Development Corp.. It is a Class 2 Radiology device (product code IYE) cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K040773 · Bionix Development Corp. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2004
Decision
14d
Days
Class 2
Risk

K040773 is an FDA 510(k) clearance for the PELVIS BELLYBOARD PLUS PATIENT POSITIONING SYSTEM. Classified as Accelerator, Linear, Medical (product code IYE), Class II - Special Controls.

Submitted by Bionix Development Corp. (Toledo, US). The FDA issued a Cleared decision on April 9, 2004 after a review of 14 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5050 - 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 Bionix Development Corp. devices

Submission Details

510(k) Number K040773 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 2004
Decision Date April 09, 2004
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
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 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 317
Devices cleared under the same product code (IYE) and FDA review panel - the closest regulatory comparables to K040773.
ON-BOARD IMAGER DEVICE
K042720 · Varian Medical Systems · Oct 2004
MODIFICATION TO: ON-BOARD IMAGER DEVICE
K041519 · Varian Medical Systems, Inc. · Aug 2004
EXACTRAC 4.0 AND EXACTRAC X-RAY 6D
K040585 · Brainlab AG · May 2004
ON-BOARD IMAGER DEVICE
K040192 · Varian Medical Systems, Inc. · Feb 2004
TRILOGY RADIOTHERAPY DELIVERY SYSTEM
K033343 · Varian Medical Systems, Inc. · Dec 2003
EXACTRAC GATING
K033287 · Brainlab AG · Dec 2003