Company ยท US
Hitachi Medical Corp. of America
FDA 510(k) clearances and medical device recalls filed under this name, 1985 to 2000. Name variants (Inc, Corp, punctuation) are merged.
32510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 12 |
| ITX | Transducer, Ultrasonic, Diagnostic | 6 |
| KPS | System, Tomography, Computed, Emission | 5 |
| DXK | Echocardiograph | 4 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 2 |
| HGL | Transducer, Ultrasonic, Obstetric | 1 |
| IZI | System, X-Ray, Angiographic | 1 |
| JAF | Monitor, Ultrasonic, Nonfetal | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 29, 2000 | K994026 | EUB-6000 ULTRASOUND DIAGNOSTIC SCANNER Hitachi Medical Corp. of America | IYN |
| Jul 30, 1999 | K991535 | CONVERGENCE CDR FOR HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERAS Hitachi Medical Corp. of America | KPS |
| Jun 18, 1999 | K991318 | CONVERGENCE NUA FOR HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERAS Hitachi Medical Corp. of America | KPS |
| May 13, 1999 | K991129 | HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERA SYSTEM WITH THICK NAL(TI) CRYSTAL Hitachi Medical Corp. of America | KPS |
| Jul 27, 1998 | K981434 | EUP-OL334 LAPARASCOPICPROBE Hitachi Medical Corp. of America | ITX |
| May 7, 1997 | K954220 | EUB-8000 Hitachi Medical Corp. of America | IYN |
| Jul 17, 1996 | K962308 | EUB-905 Hitachi Medical Corp. of America | IYO |
| Dec 22, 1995 | K954143 | HITACHI SPECTRADIGITAL SERIES GAMMA CAMERA SYSTEMS Hitachi Medical Corp. of America | KPS |
| Dec 22, 1995 | K954129 | SPECTRADIGITAL SERIES V250DSP Hitachi Medical Corp. of America | KPS |
| Nov 20, 1995 | K945400 | HITACHI DYNAMIC 3D IMAGING SYSTEM,SF-VA100 Hitachi Medical Corp. of America | IZI |
| Oct 27, 1995 | K945795 | EUB-555A+ Hitachi Medical Corp. of America | IYO |
| Aug 26, 1992 | K912364 | ELECTRONIC ULTRASOUND SCANNER EUB-315, MODIFIED Hitachi Medical Corp. of America | ITX |
| Aug 27, 1991 | K912363 | ELECTRONIC ULTRASOUND SCAN MODELS EUP-U12/012T/TC3 Hitachi Medical Corp. of America | ITX |
| Feb 25, 1991 | K905294 | EUB-315 Hitachi Medical Corp. of America | IYO |
| Jan 24, 1991 | K896100 | EUB-565 DIAGNOSTIC ULTRASOUND DEVICE Hitachi Medical Corp. of America | IYO |
| Sep 13, 1990 | K897042 | EUB-515 DIAGNOSTIC ULTRASOUND DEVICE Hitachi Medical Corp. of America | IYO |
| Sep 12, 1990 | K900966 | EUP-V12 5.0 MHZ CONVEX ARRAY TRANSVAGINAL PROBE Hitachi Medical Corp. of America | HGL |
| Sep 4, 1990 | K901658 | ADD'L TRANSDUCER FOR USE W/EUB-165 ULTRASOUND Hitachi Medical Corp. of America | DXK |
| Sep 4, 1990 | K901657 | ADD'L TRANSDUCER FOR USE W/EUB-565 ULTRASOUND Hitachi Medical Corp. of America | DXK |
| Aug 31, 1990 | K900683 | SEVEN ADD'L TRANSDUCERS FOR THE EUB-450 ULTRASOUND Hitachi Medical Corp. of America | ITX |
| Apr 13, 1990 | K890532 | EUP-C321 5.0MHZ CONVEX TYPE PROBE Hitachi Medical Corp. of America | ITX |
| Apr 13, 1990 | K890531 | EUP-F124 5.0 MHZ CONVEX ARRAY FINGER TOP PROBE Hitachi Medical Corp. of America | ITX |
| Apr 13, 1990 | K884644 | ADDIT. TRANS. EUP-B31/033J/V33/U33/032T/L33/U322 Hitachi Medical Corp. of America | IYO |
| Mar 22, 1990 | K895326 | EUB-165 Hitachi Medical Corp. of America | DXK |
| Jun 23, 1988 | K874211 | EUB-450 DIAGNOSTIC ULTRASOUND DEVICE Hitachi Medical Corp. of America | IYO |
| Apr 22, 1988 | K870878 | EUB-305 DIAGNOSTIC ULTRASOUND DEVICE Hitachi Medical Corp. of America | DXK |
| Dec 11, 1987 | K871004 | EUB-410 DIAGNOSTIC ULTRASOUND DEVICE Hitachi Medical Corp. of America | IYO |
| Jan 5, 1987 | K862867 | EUB-310 ULTRASONIC SCANNER Hitachi Medical Corp. of America | IYO |
| Dec 12, 1986 | K863576 | EUB-400 DIAGNOSTIC ULTRASOUND DEVICE Hitachi Medical Corp. of America | IYO |
| Nov 28, 1986 | K862165 | ELECTRONIC ULTRASOUND SCANNER, MODEL EUB-340 Hitachi Medical Corp. of America | IYO |
| Nov 4, 1986 | K862164 | EUP-012I, EUP-012J & EUB-0124 ULTRASONIC SCANNER Hitachi Medical Corp. of America | IYO |
| Feb 25, 1985 | K844128 | EUB-40 Hitachi Medical Corp. of America | JAF |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||