The following data is part of a premarket notification filed by Shimadzu Medical Systems with the FDA for Shimadzu Image Amplifier Ia-12vsa Series.
Device ID | K922012 |
510k Number | K922012 |
Device Name: | SHIMADZU IMAGE AMPLIFIER IA-12VSA SERIES |
Classification | System, X-ray, Fluoroscopic, Image-intensified |
Applicant | SHIMADZU MEDICAL SYSTEMS 101 WEST WALNUT ST. Gardenia, CA 90248 |
Contact | De Ming |
Correspondent | De Ming SHIMADZU MEDICAL SYSTEMS 101 WEST WALNUT ST. Gardenia, CA 90248 |
Product Code | JAA |
CFR Regulation Number | 892.1650 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-04-29 |
Decision Date | 1992-06-16 |