The following data is part of a premarket notification filed by Shimadzu Corp. with the FDA for Shimadzu Collimator R-20j.
| Device ID | K101036 |
| 510k Number | K101036 |
| Device Name: | SHIMADZU COLLIMATOR R-20J |
| Classification | Collimator, Manual, Radiographic |
| Applicant | SHIMADZU CORP. 20101 SOUTH VERMONT AVE. Torrance, CA 90502 -1328 |
| Contact | Donald Karle |
| Correspondent | Donald Karle SHIMADZU CORP. 20101 SOUTH VERMONT AVE. Torrance, CA 90502 -1328 |
| Product Code | IZX |
| CFR Regulation Number | 892.1610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-04-14 |
| Decision Date | 2010-08-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04540217060115 | K101036 | 000 |
| 04540217059546 | K101036 | 000 |
| 04540217052011 | K101036 | 000 |