Cleared Traditional

K071534 - CONFIRMA BREAST MRI INTERVENTIONAL COMPONENTS

K071534 is an FDA 510(k) clearance for CONFIRMA BREAST MRI INTERVENTIONAL COMP..., manufactured by Confirma, Inc.. The device is a Class 2 Radiology device with product code MOS cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K071534 · Confirma, Inc. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2007
Decision
34d
Days
Class 2
Risk

K071534 is an FDA 510(k) clearance for the CONFIRMA BREAST MRI INTERVENTIONAL COMPONENTS. Classified as Coil, Magnetic Resonance, Specialty (product code MOS), Class II - Special Controls.

Submitted by Confirma, Inc. (Bellevue, US). The FDA issued a Cleared decision on July 9, 2007 after a review of 34 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.

FDA 510(k) Submission Details - K071534

510(k) Number K071534 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 2007
Decision Date July 09, 2007
Days to Decision 34 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
73d faster than avg
Panel avg: 107d · This submission: 34d
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 489
Devices cleared under the same product code (MOS) and FDA review panel - the closest regulatory comparables to K071534.
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MODEL CG-WHC18-H150-AP - WRIST HAND COIL 1.5T 4 CH,
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K071611 · Neocoil · Jun 2007
NORAS OR HEAD HOLDER
K071179 · Siemens Medical Solutions USA, Inc. · Jun 2007
NEOCOIL 1.5T 8-CHANNEL SHOULDER ARRAY COIL
K071311 · Neocoil · May 2007
K071534 · CONFIRMA BREAST MRI INTERVENTIONAL COMPONENTS
Download PDF FDA Summary Confirma, Inc.