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510(k) K011582

QCU ANALYTICAL SOFTWARE PACKAGE by Medis Medical Imaging Systems BV — Product Code LLZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 31, 2001
Date Received
May 23, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Image Processing, Radiological
Device Class
Class II
Regulation Number
892.2050
Review Panel
RA
Submission Type

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  • K042383 — RSA-CMS (October 20, 2004)
  • K041162 — ORTHO-CMS (July 27, 2004)
  • K040746 — MRA-CMS (June 8, 2004)
  • K033774 — CT-MASS (March 2, 2004)

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