Cleared Traditional

K901888 - PROSTATE PROBE SURFACE COIL, CATALOG #BPX-15

K901888 is an FDA 510(k) clearance for PROSTATE PROBE SURFACE COIL, manufactured by Medrad, Inc.. The device is a Class 2 Radiology device with product code LNH cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K901888 · Medrad, Inc. · Radiology device
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Aug 1990
Decision
106d
Days
Class 2
Risk

K901888 is an FDA 510(k) clearance for the PROSTATE PROBE SURFACE COIL, CATALOG #BPX-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 August 10, 1990 after a review of 106 days - within the typical 510(k) review window.

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

FDA 510(k) Submission Details - K901888

510(k) Number K901888 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 1990
Decision Date August 10, 1990
Days to Decision 106 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
1d faster than avg
Panel avg: 107d · This submission: 106d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 971
Devices cleared under the same product code (LNH) and FDA review panel - the closest regulatory comparables to K901888.
TESLACON (MAGNETIC RESONANCE DIAGNOSTIC DEVICE)
K902933 · General Electric Co. · Aug 1990
MAG RESON DIAG DEV ACCESS SPEC PURP REC ONLY COIL
K901952 · Siemens Medical Solutions USA, Inc. · Aug 1990
MAGNETIC RESONANCE DIAGNOSTIC DEVICE
K903319 · GE Medical Systems · Aug 1990
LARGE FLEXIBLE BODY COIL
K902314 · Toshiba America Mri, Inc. · Aug 1990
SOFTWARE RELEASE 4.2P, ACCESS(TM)
K902310 · Toshiba America Mri, Inc. · Aug 1990
CERVICAL COIL MRT 50A
K902315 · Toshiba America Mri, Inc. · Aug 1990