Cleared Traditional

K930779 - MRINNERVU DISPOSABLE ENDORECTAL CERVIX ...

K930779 is the FDA 510(k) clearance for MRINNERVU DISPOSABLE ENDORECTAL CERVIX ... by Medrad, Inc.. It is a Class 2 Radiology device (product code LNH) cleared through the Traditional 510(k) pathway after a 233-day FDA review.

K930779 · Medrad, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1993
Decision
233d
Days
Class 2
Risk

K930779 is an FDA 510(k) clearance for the MRINNERVU DISPOSABLE ENDORECTAL CERVIX COIL#BCR-15. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Medrad, Inc. (Pittsburgh, US). The FDA issued a Cleared decision on October 7, 1993 after a review of 233 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 Medrad, Inc. devices

Submission Details

510(k) Number K930779 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 1993
Decision Date October 07, 1993
Days to Decision 233 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
126d slower than avg
Panel avg: 107d · This submission: 233d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 817
Devices cleared under the same product code (LNH) and FDA review panel - the closest regulatory comparables to K930779.
MRT-50A, MRT-150A
K926001 · Toshiba America Mri, Inc. · Oct 1993
MRT-150A MRI SYSTEM W/SUPER PERFORMANCE PACKAGE
K925286 · Toshiba America Mri, Inc. · Oct 1993
GYREX V-DIX & 2T-DIX SOFTWARE VERSION 3.0
K925985 · Elscint, Inc. · Oct 1993
ARTOSCAN
K931022 · Biosound, Inc. · Oct 1993
EDGE SYSTEM
K932693 · Philips Medical Systems (Cleveland), Inc. · Oct 1993
MRINNERVU DISPOSABLE ENDORECTAL COLON COIL,#PCC-15
K930544 · Medrad, Inc. · Sep 1993