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510(k) K851812

DIGITAL SUBTRACTION ANTIOGRAPHY PHANTOM 76-700/711 by Victoreen, Inc. — Product Code IXF

K851812 is an FDA 510(k) premarket notification submitted by Victoreen, Inc. for the device "DIGITAL SUBTRACTION ANTIOGRAPHY PHANTOM 76-700/711". The FDA issued a decision of Substantially Equivalent on June 5, 1985. The device falls under product code IXF (Test-Pattern, Radiographic), a Class I device regulated under 21 CFR 892.1940. Victoreen, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 5, 1985
Date Received
April 26, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Test-Pattern, Radiographic
Device Class
Class I
Regulation Number
892.1940
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 IXF

  • K865100 — TISSUE-EQUIVALENT BREAST SIMULATOR (January 12, 1987)
  • K834481 — DOPPLER PHANTOM FLOW CONTROL SYS (January 25, 1984)
  • K834482 — TISSUE MIMICKING ULTRASOUND PHANTOMS (January 25, 1984)
  • K810254 — 1.5` FOCAL SPOT RESOLUTION PATTERN (February 19, 1981)

FDA data resources