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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
Combination Product No
PCCP Authorized No
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 Consultant

Regulatory Technology Services, LLC
MARK JOB

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - LNH System, Nuclear Magnetic Resonance Imaging

All 1107
Devices cleared under the same product code (LNH) and FDA review panel - the closest regulatory comparables to K121545.
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K121545 · BELLYBOARD, SBRT ACCESSORIES
Download PDF FDA Summary Medtec Inc. Dba Civco…