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510(k) K944772

MULTIPLE ED1600 SERIES RADIATION SHIELDS by Image Diagnostics, Inc. — Product Code EAK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 20, 1994
Date Received
September 27, 1994
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 Image Diagnostics, Inc.

  • K950631 — ID400 SERIES ARMBOARDS (March 24, 1995)
  • K942190 — ID100 MOBILE FLUOROSCOPIC EXAMINING TABLE (August 17, 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)
  • 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)