Cleared Traditional

K904146 - NEURO VISION RADIOGRAPHIC X-RAY SYSTEM

K904146 is an FDA 510(k) clearance for NEURO VISION RADIOGRAPHIC X-RAY SYSTEM, manufactured by Mallinckrodt Group, Inc.. The device is a Class 2 Radiology device with product code KPR cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K904146 · Mallinckrodt Group, Inc. · Radiology device
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Dec 1990
Decision
97d
Days
Class 2
Risk

K904146 is an FDA 510(k) clearance for the NEURO VISION RADIOGRAPHIC X-RAY SYSTEM. Classified as System, X-ray, Stationary (product code KPR), Class II - Special Controls.

Submitted by Mallinckrodt Group, Inc. (Cincinnati, US). The FDA issued a Cleared decision on December 13, 1990 after a review of 97 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1680 - 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 Mallinckrodt Group, Inc. devices

FDA 510(k) Submission Details - K904146

510(k) Number K904146 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 1990
Decision Date December 13, 1990
Days to Decision 97 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
10d faster than avg
Panel avg: 107d · This submission: 97d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KPR Device Classification - Class 2, Special Controls

Product Code KPR System, X-ray, Stationary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1680
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 - KPR System, X-ray, Stationary

All 264
Devices cleared under the same product code (KPR) and FDA review panel - the closest regulatory comparables to K904146.
FLOOR MOUNT TUBESTAND-PERFORMER-N 6610.102/S-9110
K912515 · Continental X-Ray Corp. · Sep 1991
FLOOR MOUNT TUBESTAND PERFORMER, 6610.101/S-9109
K912517 · Continental X-Ray Corp. · Sep 1991
HYDRA VISION UROLOGICAL X-RAY SYSTEM
K904145 · Mallinckrodt Group, Inc. · Dec 1990
HUGH YOUNG II UROLOGICAL X-RAY SYSTEM
K904147 · Mallinckrodt Group, Inc. · Dec 1990
RADIOPAQUE RULER
K902606 · Professional Medical Services · Sep 1990
SHIMADZU X-RAY HIGH VOLTAGE GENERATOR UD150B
K884477 · Shimadzu Precision Instruments, Inc. · Mar 1989