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510(k) K013496

MODIFICATION TO SKYLIGHT IMAGING SYSTEM by Adac Laboratories — Product Code KPS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 6, 2001
Date Received
October 22, 2001
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

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  • K051351 — PRECEDENCE SPECT/CT IMAGING SYSTEM (June 8, 2005)
  • K042880 — JETSTREAM WORKSPACE (November 3, 2004)
  • K042903 — AUTOSPECS (October 29, 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)

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