The following data is part of a premarket notification filed by New Medical Co., Ltd. with the FDA for Saturn 8000.
| Device ID | K120380 |
| 510k Number | K120380 |
| Device Name: | SATURN 8000 |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | NEW MEDICAL CO., LTD. 1441 KEM WAY Walnut, CA 91789 |
| Contact | Jun-hsiung Lin |
| Correspondent | Jun-hsiung Lin NEW MEDICAL CO., LTD. 1441 KEM WAY Walnut, CA 91789 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-02-07 |
| Decision Date | 2012-03-09 |
| Summary: | summary |