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510(k) K900932

37-702 AND 37-703 PC RAINBOW by Victoreen, Inc. — Product Code IYI

K900932 is an FDA 510(k) premarket notification submitted by Victoreen, Inc. for the device "37-702 AND 37-703 PC RAINBOW". The FDA issued a decision of Substantially Equivalent on December 5, 1990. The device falls under product code IYI (Collimator, Orthovoltage, Therapeutic X-Ray), 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
December 5, 1990
Date Received
February 28, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Collimator, Orthovoltage, Therapeutic X-Ray
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 IYI

  • K914821 — CRS RADIATION BEAM SCANNER (December 17, 1992)

FDA data resources