The following data is part of a premarket notification filed by Stentor, Inc. with the FDA for Isite Radiology.
| Device ID | K013630 |
| 510k Number | K013630 |
| Device Name: | ISITE RADIOLOGY |
| Classification | System, Image Processing, Radiological |
| Applicant | STENTOR, INC. 16303 PANORAMIC WAY San Leandro, CA 94578 |
| Contact | Gary J Allsebrook |
| Correspondent | Mark Job TUV PRODUCT SERVICE, 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 | 2001-11-05 |
| Decision Date | 2001-12-05 |
| Summary: | summary |