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510(k) K841905

DOT-A, DOT-AR PXP-E, PXP-ER by Siemens Gammasonics, Inc. — Product Code JWM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 9, 1984
Date Received
May 7, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Tomographic, Nuclear
Device Class
Class II
Regulation Number
892.1310
Review Panel
RA
Submission Type

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  • K874473 — ADAC MODEL ARC-ST, PC STYLE DATA PROCESSING SYSTEM (July 18, 1988)
  • K873075 — ADAC MODEL ARC-5000, GAMMA CAMERA (October 30, 1987)
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  • K850885 — STARCAM DATA ACQUISITION & PROCESSING SYS H3300C (June 6, 1985)
  • K851686 — DIGITAL GAMMA CAMERA GCA 501S (June 5, 1985)
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