Cleared Traditional

K052704 - MODEL BBD BREAST IMMOBILIZATION AND BIOPSY DEVICE

K052704 is an FDA 510(k) clearance for MODEL BBD BREAST IMMOBILIZATION AND BIO..., manufactured by Invivo Corp.. The device is a Class 2 Radiology device with product code MOS cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K052704 · Invivo Corp. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2005
Decision
36d
Days
Class 2
Risk

K052704 is an FDA 510(k) clearance for the MODEL BBD BREAST IMMOBILIZATION AND BIOPSY DEVICE. Classified as Coil, Magnetic Resonance, Specialty (product code MOS), Class II - Special Controls.

Submitted by Invivo Corp. (Pewaukee, US). The FDA issued a Cleared decision on November 3, 2005 after a review of 36 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1000 - 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 Invivo Corp. devices

FDA 510(k) Submission Details - K052704

510(k) Number K052704 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2005
Decision Date November 03, 2005
Days to Decision 36 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 107d · This submission: 36d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MOS Device Classification - Class 2, Special Controls

Product Code MOS Coil, Magnetic Resonance, Specialty
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1000
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 - MOS Coil, Magnetic Resonance, Specialty

All 339
Devices cleared under the same product code (MOS) and FDA review panel - the closest regulatory comparables to K052704.
MEDRAD 1.5T PELVIC IMAGING SYSTEM INTERFACE DEVICE
K053042 · Medrad, Inc. · Nov 2005
MODELS HRS-63-8 AND HRS-127-8 SHOULDER ARRAY COILS
K053017 · Invivo Corporation · Nov 2005
USA INSTRUMENTS 3.0T BRAIN/SPINE ARRAY
K052916 · Usa Instruments, Inc. · Nov 2005
MODIFICATION TO MEDRAD 8-RECEIVER PHASED ARRAY NEUROVASCULAR COIL FOR SIEMENS
K052827 · Medrad, Inc. · Nov 2005
1.5T 12 CHANNEL BODY ARRAY
K052584 · Usa Instruments, Inc. · Oct 2005
1.5T 16 CHANNEL BRAIN-SPINE ARRAY COIL
K052621 · Usa Instruments, Inc. · Oct 2005