The following data is part of a premarket notification filed by Philips Medical Systems, Inc. with the FDA for Inturis Suite.
| Device ID | K994210 |
| 510k Number | K994210 |
| Device Name: | INTURIS SUITE |
| Classification | System, Image Processing, Radiological |
| Applicant | PHILIPS MEDICAL SYSTEMS, INC. 710 BRIDGEPORT AVE. P.O. BOX 860 Shelton, CT 06484 |
| Contact | Frank Gianelli |
| Correspondent | Frank Gianelli PHILIPS MEDICAL SYSTEMS, INC. 710 BRIDGEPORT AVE. P.O. BOX 860 Shelton, CT 06484 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-14 |
| Decision Date | 2000-02-04 |
| Summary: | summary |