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510(k) K844620

BDS-3 BEAM DATA SCANNER by Varian Assoc., Inc. — Product Code LHO

K844620 is an FDA 510(k) premarket notification submitted by Varian Assoc., Inc. for the device "BDS-3 BEAM DATA SCANNER". The FDA issued a decision of Substantially Equivalent on July 1, 1985. The device falls under product code LHO (Instrument, Quality-Assurance, Radiologic), a Class I device regulated under 21 CFR 892.1940. Varian Assoc., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 1, 1985
Date Received
November 27, 1984
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 Varian Assoc., Inc.

  • K000922 — PROTON VISION (May 24, 2000)
  • K992762 — BRACHYVISION 6.0 (March 9, 2000)
  • K992751 — SOMAVISION (February 16, 2000)
  • K992753 — CADPLAN PLUS: 3D TREATMENT PLANNING SYSTEM (September 3, 1999)
  • K990085 — MILLENNIUM MLC -120 (February 8, 1999)
  • K980601 — VARISOURCE WRIGHT VAGINAL CUFF APPLICATOR FOR VARIAN VARISOURCE REMOTE HIGH DOSE (October 21, 1998)
  • K955844 — APPLICATORS FOR VARIAN VARISOURCE REMOTE HIGH DOSE RATE AFTERLOADER (July 26, 1996)
  • K954467 — CADPLAN BT (March 15, 1996)
  • K955774 — VARIS PORTALVISION (March 15, 1996)
  • K943224 — VARIAN MULTILEAF COLLIMATOR (February 2, 1996)

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)
  • K860100 — MRI SLICE THICKNESS & CONTIGUITY PHANTOM #76-902 (April 22, 1986)
  • K845007 — RFA-7 RADIATION FIELD ANALYZER (July 1, 1985)
  • K834483 — DIGI-X (March 5, 1984)

FDA data resources