The following data is part of a premarket notification filed by Pie Medical with the FDA for Art Lab Software.
| Device ID | K061961 |
| 510k Number | K061961 |
| Device Name: | ART LAB SOFTWARE |
| Classification | System, Image Processing, Radiological |
| Applicant | PIE MEDICAL 11460 N. MERIDIAN ST. SUITE 150 Carmel, IN 46032 |
| Contact | Carri Graham |
| Correspondent | Carri Graham PIE MEDICAL 11460 N. MERIDIAN ST. SUITE 150 Carmel, IN 46032 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-07-11 |
| Decision Date | 2006-09-06 |
| Summary: | summary |