Cleared Traditional

K041780 - NEW BRID

K041780 is an FDA 510(k) clearance for NEW BRID, manufactured by Medical Imaging Solutions, Inc.. The device is a Class 2 Radiology device with product code OWB cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K041780 · Medical Imaging Solutions, Inc. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2004
Decision
41d
Days
Class 2
Risk

K041780 is an FDA 510(k) clearance for the NEW BRID. Classified as Interventional Fluoroscopic X-ray System (product code OWB), Class II - Special Controls.

Submitted by Medical Imaging Solutions, Inc. (Jefferson, US). The FDA issued a Cleared decision on August 11, 2004 after a review of 41 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.

FDA 510(k) Submission Details - K041780

510(k) Number K041780 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2004
Decision Date August 11, 2004
Days to Decision 41 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 107d · This submission: 41d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OWB Device Classification - Class 2, Special Controls

Product Code OWB Interventional Fluoroscopic X-ray System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1650
Definition Interventional Fluoroscopy
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 - OWB Interventional Fluoroscopic X-ray System

All 324
Devices cleared under the same product code (OWB) and FDA review panel - the closest regulatory comparables to K041780.
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K041780 · NEW BRID
Download PDF FDA Summary Medical Imaging Solut…