The following data is part of a premarket notification filed by Visualization Technology, Inc. with the FDA for Pediatric Instatrak System.
| Device ID | K981998 |
| 510k Number | K981998 |
| Device Name: | PEDIATRIC INSTATRAK SYSTEM |
| Classification | System, Image Processing, Radiological |
| Applicant | VISUALIZATION TECHNOLOGY, INC. 49 PLAIN ST. North Attleboro, MA 02760 -4153 |
| Contact | Mary Mcnamara-cullinane |
| Correspondent | Mary Mcnamara-cullinane VISUALIZATION TECHNOLOGY, INC. 49 PLAIN ST. North Attleboro, MA 02760 -4153 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-06-08 |
| Decision Date | 1998-08-21 |
| Summary: | summary |