Hitachi Medical Corp. of America
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 32
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K994026 | EUB-6000 ULTRASOUND DIAGNOSTIC SCANNER | March 29, 2000 |
| K991535 | CONVERGENCE CDR FOR HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERAS | July 30, 1999 |
| K991318 | CONVERGENCE NUA FOR HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERAS | June 18, 1999 |
| K991129 | HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERA SYSTEM WITH THICK NAL(TI) CRYSTAL | May 13, 1999 |
| K981434 | EUP-OL334 LAPARASCOPICPROBE | July 27, 1998 |
| K954220 | EUB-8000 | May 7, 1997 |
| K962308 | EUB-905 | July 17, 1996 |
| K954129 | SPECTRADIGITAL SERIES V250DSP | December 22, 1995 |
| K954143 | HITACHI SPECTRADIGITAL SERIES GAMMA CAMERA SYSTEMS | December 22, 1995 |
| K945400 | HITACHI DYNAMIC 3D IMAGING SYSTEM,SF-VA100 | November 20, 1995 |
| K945795 | EUB-555A+ | October 27, 1995 |
| K912364 | ELECTRONIC ULTRASOUND SCANNER EUB-315, MODIFIED | August 26, 1992 |
| K912363 | ELECTRONIC ULTRASOUND SCAN MODELS EUP-U12/012T/TC3 | August 27, 1991 |
| K905294 | EUB-315 | February 25, 1991 |
| K896100 | EUB-565 DIAGNOSTIC ULTRASOUND DEVICE | January 24, 1991 |
| K897042 | EUB-515 DIAGNOSTIC ULTRASOUND DEVICE | September 13, 1990 |
| K900966 | EUP-V12 5.0 MHZ CONVEX ARRAY TRANSVAGINAL PROBE | September 12, 1990 |
| K901658 | ADD'L TRANSDUCER FOR USE W/EUB-165 ULTRASOUND | September 4, 1990 |
| K901657 | ADD'L TRANSDUCER FOR USE W/EUB-565 ULTRASOUND | September 4, 1990 |
| K900683 | SEVEN ADD'L TRANSDUCERS FOR THE EUB-450 ULTRASOUND | August 31, 1990 |