510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K863236Substantially Equivalent

Acuson S519b Transducer

Acuson Computed Sonography, Mountain View CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K863236 is the FDA 510(k) clearance record for ACUSON S519B TRANSDUCER, cleared for Acuson Computed Sonography on . FDA records list 24 510(k) clearances for Acuson Computed Sonography, from to . As of , FDA records show no recalls naming K863236.

Clearance record

Decision date
Received
(176 days to decision)
Review panel
Unknown
Applicant
Acuson Computed Sonography 1220 Charleston Rd., Mountain View CA
Third party review
No