The following data is part of a premarket notification filed by Inner Vision Biometrics Pty Ltd with the FDA for R2-mri Analysis System.
| Device ID | K043271 |
| 510k Number | K043271 |
| Device Name: | R2-MRI ANALYSIS SYSTEM |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | INNER VISION BIOMETRICS PTY LTD 216 STIRLING HWY Claremont, Perth, AU 6010 |
| Contact | Janet Preuss |
| Correspondent | Janet Preuss INNER VISION BIOMETRICS PTY LTD 216 STIRLING HWY Claremont, Perth, AU 6010 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-11-26 |
| Decision Date | 2005-01-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09355529000002 | K043271 | 000 |