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510(k) K103629

PET-512MC TRANSESOPHAGEAL TRANSDUCER by Toshiba America Medical Systems, In.C — Product Code ITX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 2, 2011
Date Received
December 13, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transducer, Ultrasonic, Diagnostic
Device Class
Class II
Regulation Number
892.1570
Review Panel
RA
Submission Type

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  • K122613 — VANTAGE TITAN WITH HELIOS GRADIENT MODEL MRT-1504/US (December 13, 2012)
  • K122842 — RADREX-I, SW V4.00 MODEL DRAD-3000E (October 9, 2012)
  • K121076 — ULTRAEXTEND FX, ULTRASOUND WORKSTATION PACKAGE (October 9, 2012)
  • K122109 — AQUILION ONE VISION, V4.90 (September 21, 2012)

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  • K233109 — TP Pivot Pro™ Needle Guide (December 22, 2023)
  • K231666 — Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L) (December 13, 2023)
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