The following data is part of a premarket notification filed by Agfa Corp. with the FDA for Agfa Diagnostic Center Adc, Adc Compact, And Adc Solo.
| Device ID | K000159 |
| 510k Number | K000159 |
| Device Name: | AGFA DIAGNOSTIC CENTER ADC, ADC COMPACT, AND ADC SOLO |
| Classification | System, Imaging, X-ray, Electrostatic |
| Applicant | AGFA CORP. 10 SOUTH ACADEMY ST. Greenville, SC 29601 |
| Contact | Timothy W Capehart |
| Correspondent | Timothy W Capehart AGFA CORP. 10 SOUTH ACADEMY ST. Greenville, SC 29601 |
| Product Code | IXK |
| CFR Regulation Number | 892.1630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-01-19 |
| Decision Date | 2000-02-16 |