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510(k) K883372

ALPHA MC-9S MOBIL C-ARM IMAGE INTENSIFIER UNIT by Ausonics Pty , Ltd. — Product Code JAA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 25, 1988
Date Received
August 10, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Fluoroscopic, Image-Intensified
Device Class
Class II
Regulation Number
892.1650
Review Panel
RA
Submission Type

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  • K905488 — DOPPLER UPGRADE FOR AUSONICS OPUS 1 REAL TIME SCAN (December 18, 1991)
  • K902728 — 7.5 MHZ BI PLANE RECTAL PROBE (P/N: 041-815) (February 13, 1991)
  • K896714 — AUSONICS 5000 (June 11, 1990)
  • K881979 — RESUBMITTAL OF MI 1000C MICROIMAGER (June 12, 1989)
  • K884299 — APA-C CATALOG NUMBER A-8001-C (January 10, 1989)
  • K883925 — UROIMAGER (December 15, 1988)
  • K883079 — WWDS-005 HUMAN RECTAL PROBE (December 14, 1988)

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