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510(k) K001825

STANDARD IMAGING HDR 1000 PLUS ION CHAMBER; STANDARD IMAGING IVB 1000 ION CHAMBER by Standard Imaging, Inc. — Product Code JAQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 2, 2000
Date Received
June 16, 2000
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Applicator, Radionuclide, Remote-Controlled
Device Class
Class II
Regulation Number
892.5700
Review Panel
RA
Submission Type

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  • K042733 — STANDARD IMAGING PIPSPRO QA SOFTWARE SYSTEM (November 15, 2004)
  • K040688 — STANDARD IMAGING E.IMRT CALCULATOR (May 11, 2004)
  • K013548 — STANDARD IMAGING IVB 1000 WELL CHAMBER (November 9, 2001)
  • K002833 — MODIFICATION TO STANDARD IMAGING PT 1000 ION CHAMBER (September 28, 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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