The following data is part of a premarket notification filed by Hinacom Software And Technology, Ltd. with the FDA for Miplatform Medical Imaging Suite.
| Device ID | K131424 |
| 510k Number | K131424 |
| Device Name: | MIPLATFORM MEDICAL IMAGING SUITE |
| Classification | System, Image Processing, Radiological |
| Applicant | HINACOM SOFTWARE AND TECHNOLOGY, LTD. SUITE B301, R&D PLAZA, TSINGHUA SCIENCE PARK, HAIDIAN DISTRICT Beijing, CN 100084 |
| Contact | Yi Isabelle Sun |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2013-05-17 |
| Decision Date | 2013-07-12 |
| Summary: | summary |