The following data is part of a premarket notification filed by Applicare Medical Imaging, B.v. with the FDA for Radworks Medical Imaging Software With Quality Control Module.
| Device ID | K982862 |
| 510k Number | K982862 |
| Device Name: | RADWORKS MEDICAL IMAGING SOFTWARE WITH QUALITY CONTROL MODULE |
| Classification | System, Image Processing, Radiological |
| Applicant | APPLICARE MEDICAL IMAGING, B.V. 12300 TWINBROOK PKWY. SUITE 625 Rockville, MD 20852 |
| Contact | T. Whit Athey |
| Correspondent | T. Whit Athey APPLICARE MEDICAL IMAGING, B.V. 12300 TWINBROOK PKWY. SUITE 625 Rockville, MD 20852 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-08-13 |
| Decision Date | 1998-10-21 |
| Summary: | summary |