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510(k) K042903

AUTOSPECS by Adac Laboratories — Product Code KPS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 29, 2004
Date Received
October 15, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
System, Tomography, Computed, Emission
Device Class
Class II
Regulation Number
892.1200
Review Panel
RA
Submission Type

Other clearances by Adac Laboratories

  • K062298 — APOLLO GAMMA CAMERA SYSTEM (August 23, 2006)
  • K061029 — JETSTREAM WORKSPACE (May 1, 2006)
  • K060020 — AUTOQUANT PLUS (January 20, 2006)
  • K051351 — PRECEDENCE SPECT/CT IMAGING SYSTEM (June 8, 2005)
  • K042880 — JETSTREAM WORKSPACE (November 3, 2004)
  • K041577 — PINNACLE3 RADIATION THERAPY PLANNING SYSTEM (June 25, 2004)
  • K041218 — GRIFFIN SPECT/CT IMAGING SYSTEM (May 24, 2004)
  • K041182 — SYNTEGRA (May 21, 2004)
  • K040326 — AUTOQUANT PLUS (February 25, 2004)
  • K040142 — ENSPHERE TEMPO JETSTREAM WORKSPACE CARDIOLOGY MODULE (February 6, 2004)

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