The following data is part of a premarket notification filed by Stentor Inc., A Philips Medical Systems Co. with the FDA for Isite Pacs, V 4. X.
| Device ID | K063267 |
| 510k Number | K063267 |
| Device Name: | ISITE PACS, V 4. X |
| Classification | System, Image Processing, Radiological |
| Applicant | STENTOR INC., A PHILIPS MEDICAL SYSTEMS CO. 5000 MARINA BLVD. SUITE 100 Brisbane, CA 94005 |
| Contact | Deana Wiseman |
| Correspondent | Laura Danielson TUV AMERICA, 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 | 2006-10-30 |
| Decision Date | 2006-11-09 |
| Summary: | summary |