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510(k) K060532

HDR 1000 PLUS WELL CHAMBER, MODEL 90008 by Standard Imaging, Inc. — Product Code JAQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 11, 2006
Date Received
February 28, 2006
Clearance Type
Traditional
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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  • K002833 — MODIFICATION TO STANDARD IMAGING PT 1000 ION CHAMBER (September 28, 2000)
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  • 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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