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510(k) K950571

LINEAR FR TOMOGRAPHIC SYSTEM: 0MT 8000, MODEL NO. 6681.270 by Continental X-Ray Corp. — Product Code IZF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 1995
Date Received
January 31, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Tomographic
Device Class
Class II
Regulation Number
892.1740
Review Panel
RA
Submission Type

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  • K961690 — CARDIOARC SERIES: POSITIONER C-ARM MODELS NO. 6896.001 AND 6896.105 (June 27, 1996)
  • K954581 — ARC SERIES (December 21, 1995)
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  • K934686 — MOLYBDENUM/RHODIUM FILTERS (May 26, 1994)
  • K931724 — ELECTROPHYSIOLOGY (EP) TABLE EP 2000 SERIES (June 14, 1993)
  • K925934 — WALL BUCKY HOLDERS LT. & RT. HAND, & CENTER MOUNT (March 4, 1993)
  • K921986 — PATIENT INFORMATION MANAGER (PIM) (October 16, 1992)

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