Acuson Computed Sonography

Mountain View, CA, US

Acuson Computed Sonography appears in FDA device records in Mountain View, CA. FDA records list 24 510(k) clearances between 1985-10-24 and 1990-05-23, no PMA records and no registered establishments. As of 2026-09-10, FDA records show no recalls for this company.

510(k) clearances: 24
PMA records: 0
Recall records: 0
Registered establishments: 0

510(k) clearance history

FDA records hold 24 510(k) clearances for Acuson Computed Sonography between 1985 and 1990. The busiest year on record is 1986, with 12. The most recent is 1990, with 1.

Clearances by year, as a table

510(k) clearance decisions for Acuson Computed Sonography, by decision year
Year	Clearances
1985	1
1986	12
1987	5
1988	5
1990	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K893863	ACUSON L538 TRANSDUCER	ITX	Substantially Equivalent	1990-05-23
K874028	ACUSON S328 TRANSDUCER	IYO	Substantially Equivalent	1988-06-21
K874861	ACUSON S328 TRANSDUCER FOR CARDIAC COLOR FLOW APP.	DPT	Substantially Equivalent	1988-05-11
K874363	ACUSON S228 AND S328 TRANSDUCERS FOR ABDOM. APPLI.	IYO	Substantially Equivalent	1988-05-02
K874922	ACUSON TRANSPERINEAL NEEDLE GUIDE	ITX	Substantially Equivalent	1988-02-19
K874860	ACUSON I7505 TRANSDUCER FOR INTRACAVITARY APPLICA.	ITX	Substantially Equivalent	1988-02-17
K871506	ACUSON L538 TRANSDUCER	JOP	Substantially Equivalent	1987-09-28
K871416	AUXILIARY CONTINUOUS WAVE DOPPLER TRANSDUCER	JOP	Substantially Equivalent	1987-09-28
K871239	ACUSON PHYSIOLOGICAL CONTROL MODULE	DPS	Substantially Equivalent	1987-06-05
K864578	ACUSON TV519 TRANSDUCER	HGL	Substantially Equivalent	1987-03-27
K863236	ACUSON S519B TRANSDUCER		Substantially Equivalent	1987-02-13
K861596	ACUSON S519 TRANSDUCER	JOP	Substantially Equivalent for Some Indications	1986-07-30
K861579	ACUSON L558 TRANSDUCER	JOP	Substantially Equivalent for Some Indications	1986-07-30
K862159	ACUSON S319 TRANSDUCER	JOP	Substantially Equivalent	1986-07-24
K861866	ACUSON L382 AND L312 TRANSDUCERS	JOP	Substantially Equivalent	1986-07-18
K861577	ACUSON S228, S519 & L558 TRANSDUCERS	HGL	Substantially Equivalent	1986-06-19
K861578	ACUSON S328, L382, L538 & L312 TRANSDUCERS	HGL	Substantially Equivalent	1986-06-17
K854787	ACUSON L538 TRANSDUCER	ITX	Substantially Equivalent for Some Indications	1986-03-03
K853966	ACUSON L312 TRANSDUCER	ITX	Substantially Equivalent	1986-02-20
K854429	ACUSON NEEDLE GUIDE SYSTEM	ITX	Substantially Equivalent	1986-02-07
K854788	ACUSON AL538 TRANSDUCER	ITX	Substantially Equivalent	1986-01-15
K854786	ACUSON BL538 TRANSDUCER	ITX	Substantially Equivalent	1986-01-15
K854785	ACUSON AL558 TRANSDUCER	ITX	Substantially Equivalent	1986-01-15
K852974	ACUSON RADIOLOGY DOPPLER ACCESSORY	ITX	Substantially Equivalent for Some Indications	1985-10-24

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain