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510(k) K952233

CLEAR-PB LEAD PLASTIC OVERHEAD BARRIER 56-628 by Victoreen, Inc. — Product Code EAK

K952233 is an FDA 510(k) premarket notification submitted by Victoreen, Inc. for the device "CLEAR-PB LEAD PLASTIC OVERHEAD BARRIER 56-628". The FDA issued a decision of Substantially Equivalent on June 16, 1995. 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
June 16, 1995
Date Received
May 12, 1995
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)
  • 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)
  • K934549 — ALL-VUE ULTRA-LITE THIN WALL SYRINGE SHIELD (February 19, 1994)

Other clearances for product code EAK

  • 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)
  • K850814 — MODULAR X-RAY BARRIERS (April 10, 1985)

FDA data resources