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510(k) K962335

MLC FIT by Impac Medical Systems, Inc. — Product Code IYE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 6, 1997
Date Received
June 17, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accelerator, Linear, Medical
Device Class
Class II
Regulation Number
892.5050
Review Panel
RA
Submission Type

Other clearances by Impac Medical Systems, Inc.

  • K151233 — Monaco (July 7, 2015)
  • K141572 — MOSAIQ ONCOLOGY INFORMATION SYSTEM (September 5, 2014)
  • K132971 — MONACO (November 20, 2013)
  • K123230 — MOSAIQ ONCOLOGY INFORMATION SYSTEM (December 12, 2012)
  • K120067 — MOSAIQ ONCOLOGY INFORMATION SYSTEM (February 28, 2012)
  • K043412 — MODIFICATION TO: VIEWSTATION (December 20, 2004)
  • K013531 — QWIKSIM VIRTUAL SIMULATION SYSTEM; VERSION 2.00 (November 7, 2001)
  • K011694 — VIEWSTATION (August 29, 2001)
  • K991133 — MLC FIT (March 27, 2000)
  • K981313 — SEQUENCER (July 9, 1998)

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