The following data is part of a premarket notification filed by Philips Healthcare (cleveland) with the FDA for Iterative Reconstruction Technique Software Application.
| Device ID | K113483 |
| 510k Number | K113483 |
| Device Name: | ITERATIVE RECONSTRUCTION TECHNIQUE SOFTWARE APPLICATION |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | PHILIPS HEALTHCARE (CLEVELAND) 595 MINER RD. Cleveland, OH 44143 |
| Contact | Christine Anderson |
| Correspondent | Christine Anderson PHILIPS HEALTHCARE (CLEVELAND) 595 MINER RD. Cleveland, OH 44143 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-11-23 |
| Decision Date | 2012-09-26 |
| Summary: | summary |