The following data is part of a premarket notification filed by Visible Patient, Sas with the FDA for Visible Patient Suite.
| Device ID | K151988 |
| 510k Number | K151988 |
| Device Name: | Visible Patient Suite |
| Classification | System, Image Processing, Radiological |
| Applicant | VISIBLE PATIENT, SAS 1 PLACE DE L'HOPITAL Strasbourg, FR 67091 |
| Contact | Aude Petitjean |
| Correspondent | John J. Smith HOGAN LOVELLS US LLP 555 THIRTEENTH STREET, NW Washington, DC 20004 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-07-17 |
| Decision Date | 2015-10-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B373VPS1090 | K151988 | 000 |
| B373VPS10110 | K151988 | 000 |
| B373VPS10100 | K151988 | 000 |
| B373VPS10150 | K151988 | 000 |
| B373VPS10140 | K151988 | 000 |
| B373VPS10130 | K151988 | 000 |