Cleared Traditional

K881795 - SHIMADZU X-RAY HIGH VOLTAGE GENERATOR U...

K881795 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 1 Radiology device with product code IZO cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K881795 · Shimadzu Precision Instruments, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1988
Decision
65d
Days
Class 1
Risk

K881795 is an FDA 510(k) clearance for the SHIMADZU X-RAY HIGH VOLTAGE GENERATOR UD150K. Classified as Generator, High-voltage, X-ray, Diagnostic (product code IZO), Class I - General Controls.

Submitted by Shimadzu Precision Instruments, Inc. (Torrance, US). The FDA issued a Cleared decision on July 1, 1988 after a review of 65 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Shimadzu Precision Instruments, Inc. devices

FDA 510(k) Submission Details - K881795

510(k) Number K881795 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 1988
Decision Date July 01, 1988
Days to Decision 65 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
42d faster than avg
Panel avg: 107d · This submission: 65d
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 96
Devices cleared under the same product code (IZO) and FDA review panel - the closest regulatory comparables to K881795.
CFX 625
K883976 · Fischer Imaging Corp. · Dec 1988
MICRO-X 100CP
K884134 · Fischer Imaging Corp. · Oct 1988
3 PHASE HIGH FREQ. DIAG. X-RAY GEN. MICRO-X 60HF
K880525 · Fischer Imaging Corp. · Aug 1988
SINGLE PHASE DIAG. X-RAY GENERATOR MICRO-X 650
K880519 · Fischer Imaging Corp. · May 1988
SINGLE PHASE DIAGNOSTIC X-RAY GENERATOR FX-650
K880521 · Fischer Imaging Corp. · May 1988
THREE PHASE, DIAGNOSTIC X-RAY GENERATOR MICRO-X 80
K880522 · Fischer Imaging Corp. · May 1988