The following data is part of a premarket notification filed by Shimadzu Precision Instruments, Inc. with the FDA for Shimadzu Digital Subtraction System Dar-1200.
| Device ID | K884598 |
| 510k Number | K884598 |
| Device Name: | SHIMADZU DIGITAL SUBTRACTION SYSTEM DAR-1200 |
| Classification | System, X-ray, Fluoroscopic, Image-intensified |
| Applicant | SHIMADZU PRECISION INSTRUMENTS, INC. 20410 EARL ST. Torrance, CA 90503 |
| Contact | Harry Demint |
| Correspondent | Harry Demint SHIMADZU PRECISION INSTRUMENTS, INC. 20410 EARL ST. Torrance, CA 90503 |
| Product Code | JAA |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-11-03 |
| Decision Date | 1989-04-20 |