Cleared Traditional

K945453 - UD 150L-R II

K945453 is the FDA 510(k) clearance for UD 150L-R II by Shimadzu Medical Systems. It is a Class 1 Radiology device (product code IZO) cleared through the Traditional 510(k) pathway after a 134-day FDA review.

K945453 · Shimadzu Medical Systems · Radiology device
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Mar 1995
Decision
134d
Days
Class 1
Risk

K945453 is an FDA 510(k) clearance for the UD 150L-R II. Classified as Generator, High-voltage, X-ray, Diagnostic (product code IZO), Class I - General Controls.

Submitted by Shimadzu Medical Systems (Torrance, US). The FDA issued a Cleared decision on March 21, 1995 after a review of 134 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1700 - 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 Medical Systems devices

Submission Details

510(k) Number K945453 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 1994
Decision Date March 21, 1995
Days to Decision 134 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
27d slower than avg
Panel avg: 107d · This submission: 134d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IZO Generator, High-voltage, X-ray, Diagnostic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.1700
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - IZO Generator, High-voltage, X-ray, Diagnostic

All 77
Devices cleared under the same product code (IZO) and FDA review panel - the closest regulatory comparables to K945453.
POLYDOROS SX 65 AND 80
K950883 · Siemens Medical Solutions USA, Inc. · Apr 1995
DIGITAL 625HF
K950291 · Fischer Imaging Corp. · Mar 1995
UD 150L-F
K945452 · Shimadzu Medical Systems · Mar 1995
KXO-80G
K945668 · Toshiba America Medical Systems, In.C · Dec 1994
SHIMAZU WHOLE BODY X-RAY CT SCANNER SCT-4800TF/GR
K942731 · Shimadzu Corp. · Oct 1994
MICRO X-50 HF
K944147 · Fischer Imaging Corp. · Sep 1994