SHIMADZU X-RAY HIGH VOLTAGE GENERATOR UD150L— 510(k) K913065

Name: FDA 510(k) clearance K913065
Creator: U.S. Food and Drug Administration
Published: 1991-09-16

Substantially Equivalent

Shimadzu Medical Systems

FDA 510(k) clearance K913065 for SHIMADZU X-RAY HIGH VOLTAGE GENERATOR UD150L, Substantially Equivalent on 1991-09-16. Applicant: Shimadzu Medical Systems. Device class: 1.

Clearance details

Applicant: Shimadzu Medical Systems
Product code: Code IZO
Device class: Class 1
Regulation: 21 CFR 892.1700
Advisory panel: Radiology
Date received: 1991-07-10
Decision date: 1991-09-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gardena, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code IZO

view all

K954666 — MPH50, MPH65, AND MPH801995-11-24
K953582 — HFX350, 30KW, 300MA, 1 OR 3 PHASE RADIOGRAPHIC & FLUOROSCOPIC X-RAY GENERATOR1995-09-26
K953831 — N 800 HF1995-09-08
K952822 — SHIMADZU X-RAY HIGH VILTAGE GENERATOR AHD150G1995-07-12
K952265 — MILESTONW 350/450/550HF, PCX N350/450/550HF, TOP-X 350/450/550HF RADIOGRAPHIC X-RAY GENERATOR1995-07-06

More clearances from Shimadzu Medical Systems

view all

Data sourced from openFDA. This site is unofficial and independent of the FDA.