Cleared Traditional

C-Qual M™ Breastboard (K211001) - FDA 510(k) Clearance

Also marketed or referenced as:
Monarch™ Overhead Arm Positioner

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K211001 · Medtec, Inc. Dba Civco Medical Solutions and Civco · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2021
Decision
48d
Days
Class 2
Risk

K211001 is an FDA 510(k) clearance for the C-Qual M™ Breastboard. Classified as Accelerator, Linear, Medical (product code IYE), Class II - Special Controls.

Submitted by Medtec, Inc. Dba Civco Medical Solutions and Civco (Orange City, US). The FDA issued a Cleared decision on May 20, 2021 after a review of 48 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5050 - 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 and Civco devices

Submission Details

510(k) Number K211001 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 2021
Decision Date May 20, 2021
Days to Decision 48 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
59d faster than avg
Panel avg: 107d · This submission: 48d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IYE Accelerator, Linear, Medical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5050
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 - IYE Accelerator, Linear, Medical

All 227
Devices cleared under the same product code (IYE) and FDA review panel - the closest regulatory comparables to K211001.
ExacTrac Dynamic
K211939 · Brainlab AG · Jul 2021
Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD
K210500 · Elekta Limited · Jun 2021
Fiducial Marker
K211590 · Carbon Medical Technologies, Inc. · Jun 2021
Klarity Bolus
K202747 · Klarity Medical & Equipment (GZ) Co., Ltd. · May 2021
Identify
K210835 · Varian Medical Systems, Inc. · Apr 2021
AlignRT Plus
K203387 · Vision Rt, Ltd. · Mar 2021