Cleared Traditional

K945452 - UD 150L-F

K945452 is an FDA 510(k) clearance for UD 150L-F, manufactured by Shimadzu Medical Systems. The device is a Class 1 Radiology device with product code IZO cleared through the Traditional 510(k) pathway after a 134-day FDA review.

K945452 · Shimadzu Medical Systems · Radiology device
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Mar 1995
Decision
134d
Days
Class 1
Risk

K945452 is an FDA 510(k) clearance for the UD 150L-F. 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

FDA 510(k) Submission Details - K945452

510(k) Number K945452 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.

IZO Device Classification - Class 1, General Controls

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 99
Devices cleared under the same product code (IZO) and FDA review panel - the closest regulatory comparables to K945452.
POLYDOROS SX 65 AND 80
K950883 · Siemens Medical Solutions USA, Inc. · Apr 1995
COMPACT-X
K950694 · Electromed Intl., Ltd. · Mar 1995
DIGITAL 625HF
K950291 · Fischer Imaging Corp. · Mar 1995
UD 150L-R II
K945453 · Shimadzu Medical Systems · Mar 1995
HFQ HIGH FREQUENCY RADIOGRAPHIC AND FLUROSCOPIC GENERATORS
K945731 · Bennett X-Ray Corp. · Feb 1995
KXO-80G
K945668 · Toshiba America Medical Systems, In.C · Dec 1994