Cleared Traditional

K121545 - BELLYBOARD, SBRT ACCESSORIES

K121545 is an FDA 510(k) clearance for BELLYBOARD, manufactured by Medtec Inc. Dba Civco Medical Solutions. The device is a Class 2 Radiology device with product code LNH cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K121545 · Medtec Inc. Dba Civco Medical Solutions · Radiology device
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Jun 2012
Decision
14d
Days
Class 2
Risk

K121545 is an FDA 510(k) clearance for the BELLYBOARD, SBRT ACCESSORIES. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Medtec Inc. Dba Civco Medical Solutions (Orange City, US). The FDA issued a Cleared decision on June 8, 2012 after a review of 14 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1000 - 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 Medtec Inc. Dba Civco Medical Solutions devices

FDA 510(k) Submission Details - K121545

510(k) Number K121545 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 25, 2012
Decision Date June 08, 2012
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.

LNH Device Classification - Class 2, Special Controls

Product Code LNH System, Nuclear Magnetic Resonance Imaging
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 - LNH System, Nuclear Magnetic Resonance Imaging

All 876
Devices cleared under the same product code (LNH) and FDA review panel - the closest regulatory comparables to K121545.
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S-SCAN
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ECHELON OVAL MRI SYSTEM
K113145 · Hitachi Medical Systems America, Inc. · May 2012