The following data is part of a premarket notification filed by Philips Medical Systems(cleveland), Inc. with the FDA for Allegro Imaging System.
| Device ID | K033782 |
| 510k Number | K033782 |
| Device Name: | ALLEGRO IMAGING SYSTEM |
| Classification | System, Tomography, Computed, Emission |
| Applicant | PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. 595 MINER RD. Cleveland, OH 44143 |
| Contact | Christof Littwitz |
| Correspondent | Juergen Welte TUV RHEINLAND OF NORTH AMERICA, INC. 1279 QUARRY LANE, SUITE A Pleasanton, CA 94566 |
| Product Code | KPS |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2003-12-04 |
| Decision Date | 2003-12-19 |
| Summary: | summary |