The following data is part of a premarket notification filed by Visual Medical Solutions, Llc with the FDA for Bodyviz, Model 100.
| Device ID | K090295 |
| 510k Number | K090295 |
| Device Name: | BODYVIZ, MODEL 100 |
| Classification | System, Image Processing, Radiological |
| Applicant | VISUAL MEDICAL SOLUTIONS, LLC 11874 SOUTH EVELYN CIRCLE Houston, TX 77071 |
| Contact | J. Harvey Knauss |
| Correspondent | J. Harvey Knauss VISUAL MEDICAL SOLUTIONS, LLC 11874 SOUTH EVELYN CIRCLE Houston, TX 77071 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-02-05 |
| Decision Date | 2009-03-04 |
| Summary: | summary |