The following data is part of a premarket notification filed by Philips Healthcare (cleveland) with the FDA for Imr Software Application.
Device ID | K123576 |
510k Number | K123576 |
Device Name: | IMR 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 | 2012-11-20 |
Decision Date | 2013-06-07 |
Summary: | summary |