The following data is part of a premarket notification filed by Shimadzu Precision Instruments, Inc. with the FDA for Shimadzu Whole Body X-ray Ct Scanner Sct-3000tc.
Device ID | K881674 |
510k Number | K881674 |
Device Name: | SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-3000TC |
Classification | System, X-ray, Tomography, Computed |
Applicant | SHIMADZU PRECISION INSTRUMENTS, INC. 20410 EARL ST. Torrance, CA 90503 |
Contact | Hiroyuki Hattori,phd |
Correspondent | Hiroyuki Hattori,phd SHIMADZU PRECISION INSTRUMENTS, INC. 20410 EARL ST. Torrance, CA 90503 |
Product Code | JAK |
CFR Regulation Number | 892.1750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-04-18 |
Decision Date | 1988-09-02 |