The following data is part of a premarket notification filed by Hitachi Medical Corp. with the FDA for Eub-6500 Diagnostic Ultrasound Scanner.
| Device ID | K053258 |
| 510k Number | K053258 |
| Device Name: | EUB-6500 DIAGNOSTIC ULTRASOUND SCANNER |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | HITACHI MEDICAL CORP. 1959 SUMMIT COMMERCE PARK Twinsburg, OH 44087 |
| Contact | Doug Thistlethwaite |
| Correspondent | Doug Thistlethwaite HITACHI MEDICAL CORP. 1959 SUMMIT COMMERCE PARK Twinsburg, OH 44087 |
| Product Code | IYN |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYO |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-11-22 |
| Decision Date | 2005-12-09 |
| Summary: | summary |