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510(k) K040688

STANDARD IMAGING E.IMRT CALCULATOR by Standard Imaging, Inc. — Product Code MUJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 11, 2004
Date Received
March 16, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Planning, Radiation Therapy Treatment
Device Class
Class II
Regulation Number
892.5050
Review Panel
RA
Submission Type

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  • K042733 — STANDARD IMAGING PIPSPRO QA SOFTWARE SYSTEM (November 15, 2004)
  • K013548 — STANDARD IMAGING IVB 1000 WELL CHAMBER (November 9, 2001)
  • K002833 — MODIFICATION TO STANDARD IMAGING PT 1000 ION CHAMBER (September 28, 2000)
  • K001825 — STANDARD IMAGING HDR 1000 PLUS ION CHAMBER; STANDARD IMAGING IVB 1000 ION CHAMBE (August 2, 2000)
  • K940539 — STAND IMAGING DOSE CALIBRATOR SHIELDED WORK PLATFORM (March 16, 1994)
  • K922554 — STANDARD IMAGING HDR 1000 ION CHAMBER (August 24, 1992)

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