The following data is part of a premarket notification filed by Apollo Medical Imaging Technology Pty Ltd. with the FDA for Mistar, Model V3.2.
| Device ID | K043350 |
| 510k Number | K043350 |
| Device Name: | MISTAR, MODEL V3.2 |
| Classification | System, Image Processing, Radiological |
| Applicant | APOLLO MEDICAL IMAGING TECHNOLOGY PTY LTD. 26 HOOD STREET NORTH NORTH BALWYN Melbourne, Vic, AU 3104 |
| Contact | Qing Yang |
| Correspondent | Laura Danielson TUV AMERICA, INC. 1775 OLD HIGHWAY 8 New Brighton, MN 55112 -1891 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2004-12-06 |
| Decision Date | 2004-12-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B409MISTAR320 | K043350 | 000 |