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510(k) K953430

ULTRASOUND PROBE BIOPSY ACCESSORIES by Biosound, Inc. — Product Code ITX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 24, 1995
Date Received
July 21, 1995
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

Other clearances by Biosound, Inc.

  • K971700 — BIOPSY ACCESSORY FOR ULTRASOUND TRANSDUCER (July 9, 1997)
  • K963936 — ACCESSPOINT, MED E-MAIL, DICOM READER (March 31, 1997)
  • K963262 — ARTOSCAN M (March 28, 1997)
  • K963662 — GALILEO EVOKED POTENTIALRE (February 26, 1997)
  • K953716 — INTRACAVITY TRANSDUCERS (April 17, 1996)
  • K953530 — DIAGNOSTIC ULTRASOUND TRANDUCERS P10A, P12A, PT10A, PA11-A (April 8, 1996)
  • K953759 — DIAGNOSTIC ULTRASOUND TRANSDUCER (March 1, 1996)
  • K953819 — DIAGNOSTIC ULTRASOUND TRANDUCER (March 1, 1996)
  • K955458 — ULTRASOUND PROBE BIOPSY ACCESSORIES (February 12, 1996)
  • K953579 — TEE PROBE (February 2, 1996)

Other clearances for product code ITX

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  • K250762 — ULTRASONIC PROBE UM-S20-17S (UM-S20-17S); ULTRASONIC PROBE UM-S20-20R (UM-S20-20 (July 11, 2025)
  • K250524 — Mendaera Guidance System (July 2, 2025)
  • K250469 — Accuro® 3S Needle Guide Kit (June 13, 2025)
  • K241662 — Ultrasound Transducer Cover (August 30, 2024)
  • K233965 — UltraDrape UGPIV Barrier and Securement (34-15) (August 15, 2024)
  • K241615 — Transducer Probe Cover (July 3, 2024)
  • K233109 — TP Pivot Pro™ Needle Guide (December 22, 2023)
  • K231666 — Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L) (December 13, 2023)
  • K231783 — VitroPRO (November 14, 2023)