The following data is part of a premarket notification filed by Lead Technologies Inc. with the FDA for Mipacs Html5 Web Viewer.
| Device ID | K212984 |
| 510k Number | K212984 |
| Device Name: | MiPACS HTML5 Web Viewer |
| Classification | System, Image Processing, Radiological |
| Applicant | LEAD Technologies Inc. 1927 S. Tryon Street, Suite 200 Charlotte, NC 28203 |
| Contact | William Little |
| Correspondent | Carl Alletto O Tech Inc. 8317 Belew Drive Mckinney, TX 75071 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-17 |
| Decision Date | 2021-11-12 |