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 |