The following data is part of a premarket notification filed by Agfa Corp. with the FDA for Adc Pediatric.
| Device ID | K012750 |
| 510k Number | K012750 |
| Device Name: | ADC PEDIATRIC |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| 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 | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-16 |
| Decision Date | 2001-11-14 |
| Summary: | summary |