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510(k) K850814

MODULAR X-RAY BARRIERS by Victoreen, Inc. — Product Code EAK

K850814 is an FDA 510(k) premarket notification submitted by Victoreen, Inc. for the device "MODULAR X-RAY BARRIERS". The FDA issued a decision of Substantially Equivalent on April 10, 1985. The device falls under product code EAK (Screen, Leaded, Operator Radiation Protector), a Class I device regulated under 21 CFR 892.6500. Victoreen, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 10, 1985
Date Received
February 28, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Screen, Leaded, Operator Radiation Protector
Device Class
Class I
Regulation Number
892.6500
Review Panel
RA
Submission Type

Other clearances by Victoreen, Inc.

  • K982937 — MODEL 580-006 RADIATION THERAPY IONIZATION CHAMBER (November 19, 1998)
  • K974112 — VACUDAP, MODEL 2000, 2001 (January 29, 1998)
  • K973960 — MODEL 37-185 (January 14, 1998)
  • K964952 — VERIDOSE V (FIVE), MODEL NUMBER 37-705 (July 21, 1997)
  • K964785 — VERIDOSE DIODES (June 13, 1997)
  • K971382 — PRONE BREAST POSITIONING BOARD, MODEL #37-018 (June 6, 1997)
  • K952233 — CLEAR-PB LEAD PLASTIC OVERHEAD BARRIER 56-628 (June 16, 1995)
  • K940660 — MODEL 37-720 DUAL DIODE DOSIMETRY SYSTEM (December 9, 1994)
  • K935435 — NUCLEAR ASSOC 37-08 SER, RAYCAST HP RADIO IMMOB SYST (July 29, 1994)
  • K941931 — DIAGNOSTIC X-RAY PATIENT EXPOSURE INDICATOR (May 26, 1994)

Other clearances for product code EAK

  • K952233 — CLEAR-PB LEAD PLASTIC OVERHEAD BARRIER 56-628 (June 16, 1995)
  • K944445 — ED CORP RADIATION SCREEN (May 11, 1995)
  • K944772 — MULTIPLE ED1600 SERIES RADIATION SHIELDS (October 20, 1994)
  • K896949 — MOBILE X-RAY PERSONNEL PROTECTIVE SCREENS (February 16, 1990)
  • K861019 — CEILING MOUNT COUNTERPOISED SECON RADIATION SHIELD (April 2, 1986)
  • K850816 — LEAD PLASTIC VIEWING PANELS (April 10, 1985)

FDA data resources