The following data is part of a premarket notification filed by New Medical Co., Ltd. with the FDA for Saturn 9000.
| Device ID | K063710 |
| 510k Number | K063710 |
| Device Name: | SATURN 9000 |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | NEW MEDICAL CO., LTD. 4F, NO.42, SINGZHONG RD. NEIHU DISTRICT Taipei, TW 114 |
| Contact | Young-hoon Shin |
| Correspondent | Young-hoon Shin NEW MEDICAL CO., LTD. 4F, NO.42, SINGZHONG RD. NEIHU DISTRICT Taipei, TW 114 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-12-14 |
| Decision Date | 2007-07-16 |
| Summary: | summary |