Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Diasonics, Inc. — Predicate Candidate Screening

42 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

80 daysmedian FDA review time

289 days90th percentile

42clearances measured

K-number	Device	Applicant	Decided	Review days
K962662	VINGMED SOUND COLOR FLOW MAPPING SYSTEM	Diasonics, Inc.	1997-01-02	178
K924079	CFM-800 COLOR FLOW MAPPING SYSTEM	Diasonics, Inc.	1993-09-28	411
K911435	CPA/3.5 MHZ PROBE	Diasonics, Inc.	1992-09-11	528
K905200	SACA, 3.5 MHZ PROBE	Diasonics, Inc.	1992-04-02	499
K903562	CW DOPPLER 2.25 MHZ PROBE	Diasonics, Inc.	1992-03-02	573
K903984	CW DOPPLER/4.5 MHZ	Diasonics, Inc.	1991-06-14	289
K896637	ACCESS(TM), SOFTWARE RELEASE 4.11P	Diasonics, Inc.	1990-01-22	59
K893518	MT/S SOFTWARE RELEASE 5.0.	Diasonics, Inc.	1989-10-27	172
K894290	ACCESS TM	Diasonics, Inc.	1989-09-07	76
K893881	ACCESS TM	Diasonics, Inc.	1989-06-23	28
K891452	SPECTRA ULTRASOUND SYSTEM W/COLOR FLOW MODULE	Diasonics, Inc.	1989-06-07	84
K891541	MAGNETIC RESONANCE DEVICE ACCESSORY SOFTWARE 4.0.	Diasonics, Inc.	1989-05-11	55
K884816	ACCESS(TM) MAGNETIC RESONANCE DEVICE ACCESSORY	Diasonics, Inc.	1989-02-02	77
K884607	MT/S (SOFTWARE RELEASE 3.1)	Diasonics, Inc.	1988-12-21	47
K884743	TEMPOROMANDIBULAR JOINT COIL (TMJ)	Diasonics, Inc.	1988-12-05	21
K884606	MT/S (SPINE TRANSMIT COIL)	Diasonics, Inc.	1988-12-05	31
K884603	SHOULDER TRANSMIT AND RECEIVE COILS	Diasonics, Inc.	1988-11-30	27
K884604	MT/S CARLSON SPINE COIL, PART # 100-50082500-01	Diasonics, Inc.	1988-11-30	27
K882478	100-01778-52 ULTRASOUND SYSTEM	Diasonics, Inc.	1988-10-12	118
K883516	DIASONICS MT/P IMAGING SYSTEM	Diasonics, Inc.	1988-10-07	52
K880714	DIASONICS QT ENDORECTAL 7.5 MHZ PROBE	Diasonics, Inc.	1988-04-21	59
K870967	ADMS TRANSRECTAL 7.5 MHZ PROBE	Diasonics, Inc.	1987-09-29	203
K864908	DIASONICS TRANSVAGINAL, TV 7.5 MHZ PROBE	Diasonics, Inc.	1987-03-27	102
K864812	DIASONICS SPA 3.5 MHZ, 30MM PROBE	Diasonics, Inc.	1987-03-10	91
K864758	DIASONICS SPA 5.O 27MM PROBE	Diasonics, Inc.	1987-03-10	95
K863780	ADA-1000 (ADVANCED DIGITAL ARRAY)	Diasonics, Inc.	1986-12-29	94
K860361	DIASONICS 3.5 GWA 30MM PROBE	Diasonics, Inc.	1986-05-27	117
K853432	5.0 IOP & 7.5 IOP PROBES	Diasonics, Inc.	1986-02-07	176
K851972	DIASONICS ADA400 ADVANCED DIGITAL ARRAY	Diasonics, Inc.	1985-12-31	238
K851446	UNIVERSAL SERVICE MODULE	Diasonics, Inc.	1985-10-31	203
K851860	DIASONICS DRF-200 ULTRASOUND IMAGING SYSTEM	Diasonics, Inc.	1985-10-31	188
K851973	DIASONICS, BERGER STEREOTACTIC NEOROBIOPSY	Diasonics, Inc.	1985-07-26	80
K833667	DIASONICS DLA-100	Diasonics, Inc.	1984-05-09	203
K831317	BIOPSY ATTACHMENT	Diasonics, Inc.	1983-05-18	26
K827573	DIASONICS CARDIO/IMAGING ECHOSCOPE	Diasonics, Inc.	1982-08-16	24
K820820	CARDIO REVUE CENTER	Diasonics, Inc.	1982-04-29	36
K820033	CARDIOVUE ACCESSORY CART	Diasonics, Inc.	1982-01-22	16
K813217	DIGITAL FLUROGRAPHIC IMAGING SYSTEM	Diasonics, Inc.	1981-12-29	50
K812515	CARDIAC REVIEW STATION	Diasonics, Inc.	1981-10-02	30
K811556	DC-1 CARDIAC IMAGING MODULE	Diasonics, Inc.	1981-07-10	38
K802979	DIASONICS SMALL PARTS SCANNER	Diasonics, Inc.	1981-01-22	62
K781642	RA-I	Diasonics, Inc.	1978-10-10	19

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda