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510(k) K062449

EMPOWERMR INJECTOR SYSTEM, MODEL 9730 by E-Z-Em, Inc. — Product Code IZQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 13, 2007
Date Received
August 22, 2006
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Injector, Contrast Medium, Automatic
Device Class
Class II
Regulation Number
870.1650
Review Panel
HO
Submission Type

Other clearances by E-Z-Em, Inc.

  • K071378 — MODIFICATION TO EMPOWER CT/CTA INJECTOR SYSTEM, MODELS 9800/9900 PRODUCT SERIES (June 13, 2007)
  • K063029 — EMPOWER CT/CTA INJECTOR SYSTEM, MODEL 9800/9900 (November 2, 2006)
  • K053008 — E-Z-EM ENDOSCOPIC CO2 REGULATOR (December 27, 2005)
  • K041178 — EMPOWER TRANSFER SET, (CAT. NO. 7725) (July 16, 2004)
  • K031571 — EMPOWERCTA INJECTOR SYSTEM, MODELS 9930 & 9910 & 9825 (June 19, 2003)
  • K030854 — PROTOCO2L COLON INSUFFLATOR WITH PERFORMANCE IMPROVEMENTS, MODEL 6400 (April 16, 2003)
  • K013219 — PROTOCO2L INSUFFLATOR MODEL 6400 (February 19, 2002)
  • K011160 — E-Z EM PERCUPUMP 2001 CT INJECTOR (May 16, 2001)
  • K974621 — PERCUPUMP II WITH EDA (January 27, 1998)
  • K961845 — PERCUPUMP II WITH EDA (January 23, 1997)

Other clearances for product code IZQ

  • K252281 — ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheas (November 18, 2025)
  • K251295 — ulrichINJECT CT Motion (XD 8000) (November 7, 2025)
  • K252689 — MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Pa (September 24, 2025)
  • K241849 — MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Pa (November 5, 2024)
  • K241850 — ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheas (August 26, 2024)
  • K233737 — ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheas (April 19, 2024)
  • K210541 — ulrichINJECT CT motion (August 6, 2021)
  • K192872 — ulrichINJECT CT Motion (July 2, 2020)
  • K171392 — ulrichINJECT CT motion (November 9, 2017)
  • K151048 — CT Expres 3D Contrast Media Delivery System, Bottle Spike Type B, Day Set III HP (January 22, 2016)