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510(k) K860469

37-701-1 PATIENT DOASE MONITOR WITH DETECTORS by Victoreen, Inc. — Product Code KPZ

K860469 is an FDA 510(k) premarket notification submitted by Victoreen, Inc. for the device "37-701-1 PATIENT DOASE MONITOR WITH DETECTORS". The FDA issued a decision of Substantially Equivalent on April 16, 1986. The device falls under product code KPZ (Generator, High Voltage, X-Ray, Therapeutic), a Class II device regulated under 21 CFR 892.5900. Victoreen, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 16, 1986
Date Received
February 6, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Generator, High Voltage, X-Ray, Therapeutic
Device Class
Class II
Regulation Number
892.5900
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 KPZ

  • K912249 — PATIENT DOSE MONITOR (August 30, 1991)
  • K854410 — VERIFLEX (February 12, 1986)

FDA data resources