The following data is part of a premarket notification filed by Shimadzu Corp. with the FDA for Shimadzu Image Amplifier, Model Ia-16l/hs.
| Device ID | K040870 |
| 510k Number | K040870 |
| Device Name: | SHIMADZU IMAGE AMPLIFIER, MODEL IA-16L/HS |
| Classification | System, X-ray, Fluoroscopic, Image-intensified |
| Applicant | SHIMADZU CORP. 20101 SOUTH VERMONT AVE. Torrance, CA 90502 -1328 |
| Contact | Takeshi Ozaki |
| Correspondent | Takeshi Ozaki SHIMADZU CORP. 20101 SOUTH VERMONT AVE. Torrance, CA 90502 -1328 |
| Product Code | JAA |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-04-02 |
| Decision Date | 2004-05-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04540217026104 | K040870 | 000 |
| 04540217020201 | K040870 | 000 |