Cleared Traditional

K191539 - 1.5T Endorectal Coil

K191539 is an FDA 510(k) clearance for 1.5T Endorectal Coil, manufactured by Rapid Biomedical GmbH. The device is a Class 2 Radiology device with product code MOS cleared through the Traditional 510(k) pathway after a 235-day FDA review.

K191539 · Rapid Biomedical GmbH · Radiology device
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Jan 2020
Decision
235d
Days
Class 2
Risk

K191539 is an FDA 510(k) clearance for the 1.5T Endorectal Coil, 3.0T Endorectal Coil, ER Coil Support. Classified as Coil, Magnetic Resonance, Specialty (product code MOS), Class II - Special Controls.

Submitted by Rapid Biomedical GmbH (Rimpar, DE). The FDA issued a Cleared decision on January 31, 2020 after a review of 235 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Rapid Biomedical GmbH devices

FDA 510(k) Submission Details - K191539

510(k) Number K191539 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 2019
Decision Date January 31, 2020
Days to Decision 235 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
128d slower than avg
Panel avg: 107d · This submission: 235d
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 312
Devices cleared under the same product code (MOS) and FDA review panel - the closest regulatory comparables to K191539.
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