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510(k) K041182

SYNTEGRA by Adac Laboratories — Product Code KPS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 21, 2004
Date Received
May 6, 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

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  • K042903 — AUTOSPECS (October 29, 2004)
  • K041577 — PINNACLE3 RADIATION THERAPY PLANNING SYSTEM (June 25, 2004)
  • K041218 — GRIFFIN SPECT/CT IMAGING SYSTEM (May 24, 2004)
  • K040326 — AUTOQUANT PLUS (February 25, 2004)
  • K040142 — ENSPHERE TEMPO JETSTREAM WORKSPACE CARDIOLOGY MODULE (February 6, 2004)

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