The following data is part of a premarket notification filed by Agfa Corp. with the FDA for Adc Qs/ipd Workstation.
Device ID | K010571 |
510k Number | K010571 |
Device Name: | ADC QS/IPD WORKSTATION |
Classification | System, Image Processing, Radiological |
Applicant | AGFA CORP. 12300 TWINBROOK PKWY,STE 625 Rockville, MD 20852 |
Contact | T. Whit Athey |
Correspondent | T. Whit Athey AGFA CORP. 12300 TWINBROOK PKWY,STE 625 Rockville, MD 20852 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-02-26 |
Decision Date | 2001-03-28 |