The following data is part of a premarket notification filed by Otech, Inc. with the FDA for Ids4 Image Display System Series.
| Device ID | K971368 |
| 510k Number | K971368 |
| Device Name: | IDS4 IMAGE DISPLAY SYSTEM SERIES |
| Classification | System, Image Processing, Radiological |
| Applicant | OTECH, INC. 6741 GRANT LN. Plano, TX 75024 |
| Contact | Herman Oosterwijk |
| Correspondent | Herman Oosterwijk OTECH, INC. 6741 GRANT LN. Plano, TX 75024 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-14 |
| Decision Date | 1997-06-26 |
| Summary: | summary |