Cleared Traditional

K884477 - SHIMADZU X-RAY HIGH VOLTAGE GENERATOR U...

K884477 is an FDA 510(k) clearance for SHIMADZU X-RAY HIGH VOLTAGE GENERATOR U..., manufactured by Shimadzu Precision Instruments, Inc.. The device is a Class 2 Radiology device with product code KPR cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K884477 · Shimadzu Precision Instruments, Inc. · Radiology device
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Mar 1989
Decision
141d
Days
Class 2
Risk

K884477 is an FDA 510(k) clearance for the SHIMADZU X-RAY HIGH VOLTAGE GENERATOR UD150B. Classified as System, X-ray, Stationary (product code KPR), Class II - Special Controls.

Submitted by Shimadzu Precision Instruments, Inc. (Torrance, US). The FDA issued a Cleared decision on March 15, 1989 after a review of 141 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 Shimadzu Precision Instruments, Inc. devices

FDA 510(k) Submission Details - K884477

510(k) Number K884477 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 1988
Decision Date March 15, 1989
Days to Decision 141 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
34d slower than avg
Panel avg: 107d · This submission: 141d
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 192
Devices cleared under the same product code (KPR) and FDA review panel - the closest regulatory comparables to K884477.
HYDRA VISION UROLOGICAL X-RAY SYSTEM
K904145 · Mallinckrodt Group, Inc. · Dec 1990
NEURO VISION RADIOGRAPHIC X-RAY SYSTEM
K904146 · Mallinckrodt Group, Inc. · Dec 1990
HUGH YOUNG II UROLOGICAL X-RAY SYSTEM
K904147 · Mallinckrodt Group, Inc. · Dec 1990
MEDRAD OMNIPLANE 300 SYSTEM
K883834 · Medrad, Inc. · Nov 1988
MTX GENERATOR
K880352 · Philips Medical Systems (Cleveland), Inc. · Jul 1988
BC 1400 HAND POSITIONER
K872316 · Instrumentation Industries, Inc. · Aug 1987