ESP 3-PHASE X-RAY GENERATORS— 510(k) K884678

Substantially Equivalent

Elscint, Inc.

FDA 510(k) clearance K884678 for ESP 3-PHASE X-RAY GENERATORS, Substantially Equivalent on 1989-01-17. Applicant: Elscint, Inc.. Device class: 1.

Clearance details

Applicant: Elscint, Inc.
Product code: Code IZO
Device class: Class 1
Regulation: 21 CFR 892.1700
Advisory panel: Radiology
Date received: 1988-11-08
Decision date: 1989-01-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Itasca, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code IZO

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 Elscint, Inc.

K983313 — ADVANCED AUTOMATIC DETECTOR SELECTION OPTION FOR GLORY1998-12-11
K982060 — VOLUMAX CT IMAGING SYSTEM1998-09-02
K974344 — CT SCOPE1998-06-03
K980306 — GYREX 2T PRESTIGE, GYREX PRIMA ITG, GYREX PRIVILEGE, GYREX V-EP1998-04-02
K974614 — GYREX 2T PRESTIGE 100-6321-0107, GYREX PRIVILEDGE 100-6326-0102, GYREX PRIMA 1TG 100-6250-01021998-03-04

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