The following data is part of a premarket notification filed by Otech, Inc. with the FDA for Ids4 V3.2 Image Display System.
| Device ID | K991643 |
| 510k Number | K991643 |
| Device Name: | IDS4 V3.2 IMAGE DISPLAY SYSTEM |
| Classification | System, Image Processing, Radiological |
| Applicant | OTECH, INC. 2001 EAST OAKSHORES DR. Crossroads, TX 76227 |
| Contact | Herman Oosterwijk |
| Correspondent | Herman Oosterwijk OTECH, INC. 2001 EAST OAKSHORES DR. Crossroads, TX 76227 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-05-13 |
| Decision Date | 1999-06-08 |
| Summary: | summary |