Diasonics, Inc.

Mchenry, IL, US

Diasonics, Inc. appears in FDA device records in Mchenry, IL. FDA records list 42 510(k) clearances between 1978-10-10 and 1997-01-02, 27 PMA records and no registered establishments. As of 2026-09-10, FDA records show no recalls for this company.

510(k) clearances: 42
PMA records: 27
Recall records: 0
Registered establishments: 0

510(k) clearance history

FDA records hold 42 510(k) clearances for Diasonics, Inc. between 1978 and 1997. The busiest year on record is 1988, with 8. The most recent is 1997, with 1.

Clearances by year, as a table

510(k) clearance decisions for Diasonics, Inc., by decision year
Year	Clearances
1978	1
1981	4
1982	3
1983	1
1984	1
1985	4
1986	3
1987	4
1988	8
1989	6
1990	1
1991	1
1992	3
1993	1
1997	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K962662	VINGMED SOUND COLOR FLOW MAPPING SYSTEM	IYO	Substantially Equivalent	1997-01-02
K924079	CFM-800 COLOR FLOW MAPPING SYSTEM	IYO	Substantially Equivalent	1993-09-28
K911435	CPA/3.5 MHZ PROBE	ITX	Substantially Equivalent	1992-09-11
K905200	SACA, 3.5 MHZ PROBE	ITX	Substantially Equivalent	1992-04-02
K903562	CW DOPPLER 2.25 MHZ PROBE	ITX	Substantially Equivalent	1992-03-02
K903984	CW DOPPLER/4.5 MHZ	ITX	Substantially Equivalent	1991-06-14
K896637	ACCESS(TM), SOFTWARE RELEASE 4.11P	LPH	Substantially Equivalent	1990-01-22
K893518	MT/S SOFTWARE RELEASE 5.0.	LNH	Substantially Equivalent	1989-10-27
K894290	ACCESS TM	LNH	Substantially Equivalent	1989-09-07
K893881	ACCESS TM	LNH	Substantially Equivalent	1989-06-23
K891452	SPECTRA ULTRASOUND SYSTEM W/COLOR FLOW MODULE	IYO	Substantially Equivalent	1989-06-07
K891541	MAGNETIC RESONANCE DEVICE ACCESSORY SOFTWARE 4.0.	LNH	Substantially Equivalent	1989-05-11
K884816	ACCESS(TM) MAGNETIC RESONANCE DEVICE ACCESSORY	LNH	Substantially Equivalent	1989-02-02
K884607	MT/S (SOFTWARE RELEASE 3.1)	LNH	Substantially Equivalent	1988-12-21
K884743	TEMPOROMANDIBULAR JOINT COIL (TMJ)	LNH	Substantially Equivalent	1988-12-05
K884606	MT/S (SPINE TRANSMIT COIL)	LNH	Substantially Equivalent	1988-12-05
K884604	MT/S CARLSON SPINE COIL, PART # 100-50082500-01	LNH	Substantially Equivalent	1988-11-30
K884603	SHOULDER TRANSMIT AND RECEIVE COILS	LNH	Substantially Equivalent	1988-11-30
K882478	100-01778-52 ULTRASOUND SYSTEM	IYO	Substantially Equivalent	1988-10-12
K883516	DIASONICS MT/P IMAGING SYSTEM	LNH	Substantially Equivalent	1988-10-07
K880714	DIASONICS QT ENDORECTAL 7.5 MHZ PROBE	IYO	Substantially Equivalent	1988-04-21
K870967	ADMS TRANSRECTAL 7.5 MHZ PROBE	ITX	Substantially Equivalent	1987-09-29
K864908	DIASONICS TRANSVAGINAL, TV 7.5 MHZ PROBE	HGL	Substantially Equivalent	1987-03-27
K864812	DIASONICS SPA 3.5 MHZ, 30MM PROBE	ITX	Substantially Equivalent	1987-03-10
K864758	DIASONICS SPA 5.O 27MM PROBE	ITX	Substantially Equivalent	1987-03-10
K863780	ADA-1000 (ADVANCED DIGITAL ARRAY)	IYO	Substantially Equivalent for Some Indications	1986-12-29
K860361	DIASONICS 3.5 GWA 30MM PROBE	ITX	Substantially Equivalent	1986-05-27
K853432	5.0 IOP & 7.5 IOP PROBES	GXW	Substantially Equivalent	1986-02-07
K851972	DIASONICS ADA400 ADVANCED DIGITAL ARRAY	IYO	Substantially Equivalent	1985-12-31
K851860	DIASONICS DRF-200 ULTRASOUND IMAGING SYSTEM	IYO	Substantially Equivalent	1985-10-31
K851446	UNIVERSAL SERVICE MODULE	IYO	Substantially Equivalent	1985-10-31
K851973	DIASONICS, BERGER STEREOTACTIC NEOROBIOPSY	HAW	Substantially Equivalent	1985-07-26
K833667	DIASONICS DLA-100	IYO	Substantially Equivalent	1984-05-09
K831317	BIOPSY ATTACHMENT	FCI	Substantially Equivalent	1983-05-18
K827573	DIASONICS CARDIO/IMAGING ECHOSCOPE		Substantially Equivalent	1982-08-16
K820820	CARDIO REVUE CENTER	DXG	Substantially Equivalent	1982-04-29
K820033	CARDIOVUE ACCESSORY CART	DSF	Substantially Equivalent	1982-01-22
K813217	DIGITAL FLUROGRAPHIC IMAGING SYSTEM	JAA	Substantially Equivalent	1981-12-29
K812515	CARDIAC REVIEW STATION	DXG	Substantially Equivalent	1981-10-02
K811556	DC-1 CARDIAC IMAGING MODULE	DXK	Substantially Equivalent	1981-07-10
K802979	DIASONICS SMALL PARTS SCANNER	IYN	Substantially Equivalent	1981-01-22
K781642	RA-I	IYN	Substantially Equivalent	1978-10-10

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