The following data is part of a premarket notification filed by Fujifilm Medical System U.s.a., Inc. with the FDA for Synapse 3d Lung And Abdomen Analysis.
Device ID | K130542 |
510k Number | K130542 |
Device Name: | SYNAPSE 3D LUNG AND ABDOMEN ANALYSIS |
Classification | System, Image Processing, Radiological |
Applicant | FUJIFILM MEDICAL SYSTEM U.S.A., INC. 419 WEST AVE. Stamford, CT 06902 -6300 |
Contact | Jyh-shyan Lin |
Correspondent | Jyh-shyan Lin FUJIFILM MEDICAL SYSTEM U.S.A., INC. 419 WEST AVE. Stamford, CT 06902 -6300 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-03-01 |
Decision Date | 2013-06-14 |
Summary: | summary |