The following data is part of a premarket notification filed by Mitsmed Medical Instrument Technology Co., Ltd. with the FDA for Mits Dicom Gateway And Image Manager.
| Device ID | K092581 |
| 510k Number | K092581 |
| Device Name: | MITS DICOM GATEWAY AND IMAGE MANAGER |
| Classification | System, Image Processing, Radiological |
| Applicant | MITSMED MEDICAL INSTRUMENT TECHNOLOGY CO., LTD. NO. 58 FU CHIUN STREET Hsin Chu City, TW 30067 |
| Contact | Ke-min Jen |
| Correspondent | Ke-min Jen MITSMED MEDICAL INSTRUMENT TECHNOLOGY CO., LTD. NO. 58 FU CHIUN STREET Hsin Chu City, TW 30067 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-08-21 |
| Decision Date | 2009-10-30 |
| Summary: | summary |