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510(k) K860100

MRI SLICE THICKNESS & CONTIGUITY PHANTOM #76-902 by Victoreen, Inc. — Product Code LHO

K860100 is an FDA 510(k) premarket notification submitted by Victoreen, Inc. for the device "MRI SLICE THICKNESS & CONTIGUITY PHANTOM #76-902". The FDA issued a decision of Substantially Equivalent on April 22, 1986. The device falls under product code LHO (Instrument, Quality-Assurance, Radiologic), 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
April 22, 1986
Date Received
January 10, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Quality-Assurance, Radiologic
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 LHO

  • K042733 — STANDARD IMAGING PIPSPRO QA SOFTWARE SYSTEM (November 15, 2004)
  • K873956 — ULTIMETER (October 30, 1987)
  • K860260 — MULTI PURPOSE MODEL 76-903 (May 7, 1986)
  • K853754 — MAGNETIC RESONANCE IMAGING UNIFORMITY/T1 76-901 (May 7, 1986)
  • K845007 — RFA-7 RADIATION FIELD ANALYZER (July 1, 1985)
  • K844620 — BDS-3 BEAM DATA SCANNER (July 1, 1985)
  • K834483 — DIGI-X (March 5, 1984)

FDA data resources