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Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Hitachi Medical Corp. of America · Predicate Candidate Screening

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

175 daysmedian FDA review time
455 days90th percentile
32clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K994026EUB-6000 ULTRASOUND DIAGNOSTIC SCANNERHitachi Medical Corp. of America2000-03-291240
K991535CONVERGENCE CDR FOR HITACHI SPECTRADIGITAL V250DSP GAMMA CAMHitachi Medical Corp. of America1999-07-30880
K991318CONVERGENCE NUA FOR HITACHI SPECTRADIGITAL V250DSP GAMMA CAMHitachi Medical Corp. of America1999-06-18600
K991129HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERA SYSTEM WITH THICHitachi Medical Corp. of America1999-05-13410
K981434EUP-OL334 LAPARASCOPICPROBEHitachi Medical Corp. of America1998-07-27970
K954220EUB-8000Hitachi Medical Corp. of America1997-05-076040
K962308EUB-905Hitachi Medical Corp. of America1996-07-17300
K954129SPECTRADIGITAL SERIES V250DSPHitachi Medical Corp. of America1995-12-221120
K954143HITACHI SPECTRADIGITAL SERIES GAMMA CAMERA SYSTEMSHitachi Medical Corp. of America1995-12-221120
K945400HITACHI DYNAMIC 3D IMAGING SYSTEM,SF-VA100Hitachi Medical Corp. of America1995-11-203820
K945795EUB-555A+Hitachi Medical Corp. of America1995-10-273360
K912364ELECTRONIC ULTRASOUND SCANNER EUB-315, MODIFIEDHitachi Medical Corp. of America1992-08-264550
K912363ELECTRONIC ULTRASOUND SCAN MODELS EUP-U12/012T/TC3Hitachi Medical Corp. of America1991-08-27900
K905294EUB-315Hitachi Medical Corp. of America1991-02-25900
K896100EUB-565 DIAGNOSTIC ULTRASOUND DEVICEHitachi Medical Corp. of America1991-01-244610
K897042EUB-515 DIAGNOSTIC ULTRASOUND DEVICEHitachi Medical Corp. of America1990-09-132690
K900966EUP-V12 5.0 MHZ CONVEX ARRAY TRANSVAGINAL PROBEHitachi Medical Corp. of America1990-09-121950
K901657ADD'L TRANSDUCER FOR USE W/EUB-565 ULTRASOUNDHitachi Medical Corp. of America1990-09-041470
K901658ADD'L TRANSDUCER FOR USE W/EUB-165 ULTRASOUNDHitachi Medical Corp. of America1990-09-041470
K900683SEVEN ADD'L TRANSDUCERS FOR THE EUB-450 ULTRASOUNDHitachi Medical Corp. of America1990-08-311990
K884644ADDIT. TRANS. EUP-B31/033J/V33/U33/032T/L33/U322Hitachi Medical Corp. of America1990-04-135220
K890531EUP-F124 5.0 MHZ CONVEX ARRAY FINGER TOP PROBEHitachi Medical Corp. of America1990-04-134350
K890532EUP-C321 5.0MHZ CONVEX TYPE PROBEHitachi Medical Corp. of America1990-04-134350
K895326EUB-165Hitachi Medical Corp. of America1990-03-222050
K874211EUB-450 DIAGNOSTIC ULTRASOUND DEVICEHitachi Medical Corp. of America1988-06-232510
K870878EUB-305 DIAGNOSTIC ULTRASOUND DEVICEHitachi Medical Corp. of America1988-04-224150
K871004EUB-410 DIAGNOSTIC ULTRASOUND DEVICEHitachi Medical Corp. of America1987-12-112740
K862867EUB-310 ULTRASONIC SCANNERHitachi Medical Corp. of America1987-01-051600
K863576EUB-400 DIAGNOSTIC ULTRASOUND DEVICEHitachi Medical Corp. of America1986-12-12910
K862165ELECTRONIC ULTRASOUND SCANNER, MODEL EUB-340Hitachi Medical Corp. of America1986-11-281750
K862164EUP-012I, EUP-012J & EUB-0124 ULTRASONIC SCANNERHitachi Medical Corp. of America1986-11-041510
K844128EUB-40Hitachi Medical Corp. of America1985-02-251250

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