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510(k) K954310

BLA-800A by Toshiba Medical Systems — Product Code KPW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 18, 1995
Date Received
September 15, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Beam Limiting, X-Ray, Diagnostic
Device Class
Class II
Regulation Number
892.1610
Review Panel
RA
Submission Type

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  • K891453 — DIAGNOSTIC ULTRASOUND TRANSDUCER: PVE-582V (June 1, 1989)
  • K890969 — TRANSESOPHAGEAL TRANSDUCER PEF-511SA (May 16, 1989)
  • K884555 — TCT-600HQ COMPU TOMO(CT)XRAY/HEAD/WHOLE BODY EXAM (February 27, 1989)
  • K884788 — TOSHIBA TCT-600XT COMPUTED TOMOGRAPHY X-RAY SYSTEM (February 27, 1989)
  • K883359 — DIAGNOSTIC ULTRASOUND SYSTEM SSA-270A (January 25, 1989)
  • K883756 — TOSHIBA MRT-50A MAGNETIC RESONANCE SYSTEM (November 14, 1988)
  • K881305 — TCT-300S COMPUTED TOMO. (CT) X-RAY SYSTEM FOR EXAM (October 19, 1988)

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