The following data is part of a premarket notification filed by Seibu Techno Coproration with the FDA for Sk S-ray Grids.
| Device ID | K945697 |
| 510k Number | K945697 |
| Device Name: | SK S-RAY GRIDS |
| Classification | Grid, Radiographic |
| Applicant | SEIBU TECHNO COPRORATION NO. 107 KAMI-UCHIMAGI, ASAKA CITY, SAITAMA PREF. 351 Japan, JP |
| Contact | Hideto Ichikawa |
| Correspondent | Hideto Ichikawa SEIBU TECHNO COPRORATION NO. 107 KAMI-UCHIMAGI, ASAKA CITY, SAITAMA PREF. 351 Japan, JP |
| Product Code | IXJ |
| CFR Regulation Number | 892.1910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-17 |
| Decision Date | 1995-01-31 |