The following data is part of a premarket notification filed by Philips Medical Systems, Inc. with the FDA for Acqplan 5.0.
| Device ID | K013644 |
| 510k Number | K013644 |
| Device Name: | ACQPLAN 5.0 |
| Classification | System, Planning, Radiation Therapy Treatment |
| Applicant | PHILIPS MEDICAL SYSTEMS, INC. 595 MINER RD. Highland Hgts., OH 44143 |
| Contact | Robert L Turocy |
| Correspondent | Robert L Turocy PHILIPS MEDICAL SYSTEMS, INC. 595 MINER RD. Highland Hgts., OH 44143 |
| Product Code | MUJ |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-11-05 |
| Decision Date | 2002-09-12 |
| Summary: | summary |