The following data is part of a premarket notification filed by Shimadzu Medical Systems with the FDA for Shimadzu Image Amplifier Ia-12vma Series.
| Device ID | K922013 |
| 510k Number | K922013 |
| Device Name: | SHIMADZU IMAGE AMPLIFIER IA-12VMA SERIES |
| Classification | System, X-ray, Fluoroscopic, Image-intensified |
| Applicant | SHIMADZU MEDICAL SYSTEMS 101 WEST WALNUT ST. Gardenia, CA 90248 |
| Contact | De Mint |
| Correspondent | De Mint 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 | 1992-06-10 |