The following data is part of a premarket notification filed by Shimadzu Corp. with the FDA for Shimadzu Image Amplifier Model # Ia-16lm.
| Device ID | K012424 |
| 510k Number | K012424 |
| Device Name: | SHIMADZU IMAGE AMPLIFIER MODEL # IA-16LM |
| Classification | System, X-ray, Fluoroscopic, Image-intensified |
| Applicant | SHIMADZU CORP. 20101 SOUTH VERMONT AVE. Torrance, CA 90502 -1328 |
| Contact | Michael Fishback |
| Correspondent | Michael Fishback 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 | 2001-07-30 |
| Decision Date | 2001-10-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04540217046973 | K012424 | 000 |
| 04540217026111 | K012424 | 000 |
| 04540217026098 | K012424 | 000 |
| 04540217026081 | K012424 | 000 |
| 04540217026074 | K012424 | 000 |
| 04540217026067 | K012424 | 000 |
| 04540217020249 | K012424 | 000 |
| 04540217020232 | K012424 | 000 |
| 04540217020225 | K012424 | 000 |
| 04540217020218 | K012424 | 000 |
| 04540217020195 | K012424 | 000 |
| 04540217020188 | K012424 | 000 |
| 04540217020171 | K012424 | 000 |
| 04540217020164 | K012424 | 000 |
| 04540217020140 | K012424 | 000 |
| 04540217020133 | K012424 | 000 |
| 04540217020126 | K012424 | 000 |
| 04540217026128 | K012424 | 000 |
| 04540217026135 | K012424 | 000 |
| 04540217031726 | K012424 | 000 |
| 04540217032075 | K012424 | 000 |
| 04540217032068 | K012424 | 000 |
| 04540217032037 | K012424 | 000 |
| 04540217032020 | K012424 | 000 |
| 04540217032013 | K012424 | 000 |
| 04540217031986 | K012424 | 000 |
| 04540217031979 | K012424 | 000 |
| 04540217031962 | K012424 | 000 |
| 04540217031931 | K012424 | 000 |
| 04540217031924 | K012424 | 000 |
| 04540217031917 | K012424 | 000 |
| 04540217031894 | K012424 | 000 |
| 04540217031887 | K012424 | 000 |
| 04540217031870 | K012424 | 000 |
| 04540217031863 | K012424 | 000 |
| 04540217031856 | K012424 | 000 |
| 04540217019274 | K012424 | 000 |