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510(k) K940539

STAND IMAGING DOSE CALIBRATOR SHIELDED WORK PLATFORM by Standard Imaging, Inc. — Product Code KPY

K940539 is an FDA 510(k) premarket notification submitted by Standard Imaging, Inc. for the device "STAND IMAGING DOSE CALIBRATOR SHIELDED WORK PLATFORM". The FDA issued a decision of Substantially Equivalent on March 16, 1994. The device falls under product code KPY (Shield, Protective, Personnel), a Class I device regulated under 21 CFR 892.6500. Standard Imaging, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 16, 1994
Date Received
February 7, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Shield, Protective, Personnel
Device Class
Class I
Regulation Number
892.6500
Review Panel
RA
Submission Type

Other clearances by Standard Imaging, Inc.

  • K103193 — DOSEVIEW 3D (December 27, 2010)
  • K082773 — STANDARD IMAGING IMSURE BRACHY QA SOFTWARE, MODEL 91331 (November 19, 2008)
  • K060532 — HDR 1000 PLUS WELL CHAMBER, MODEL 90008 (April 11, 2006)
  • 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)
  • K001825 — STANDARD IMAGING HDR 1000 PLUS ION CHAMBER; STANDARD IMAGING IVB 1000 ION CHAMBE (August 2, 2000)
  • K922554 — STANDARD IMAGING HDR 1000 ION CHAMBER (August 24, 1992)

Other clearances for product code KPY

  • K110900 — DISPOSABLE THYROID COLLAR (June 24, 2011)
  • K962622 — INTRA-ORAL THERMOPLASTIC SHIELD (October 1, 1996)
  • K954456 — THERMOPLASTIC SHIELD (December 21, 1995)
  • K954146 — UTK-DTE AUTILARY SHIELD (December 6, 1995)
  • K953610 — AUKULYTE (September 26, 1995)
  • K951004 — 2001 SPECIAL PROCEDURE LAMP (LOW VOLTAGE) (AS EXHIBITS #2 & 4) (April 10, 1995)
  • K951003 — KENEX RADIATION SHIELD (VARIOUS MODELS AS EXHIBITS #2 & 5) (April 3, 1995)
  • K934206 — MAVIG ANGIO SHIELD MODELS 6290 & 6272 (October 7, 1993)
  • K912326 — DAVIS LEAD APRON - VARIOUS CATALOGUE NUMBERS (March 18, 1992)
  • K912327 — DAVIS LEAD APRON GONADAL SHIELD-VARIOUS CAT. NOS. (March 18, 1992)

FDA data resources