The following data is part of a premarket notification filed by Del Medical Imaging Corp. with the FDA for Del-ims.
| Device ID | K063188 |
| 510k Number | K063188 |
| Device Name: | DEL-IMS |
| Classification | System, Image Processing, Radiological |
| Applicant | DEL MEDICAL IMAGING CORP. 11550 WEST KING ST. Franklin Park, IL 60131 |
| Contact | William J Engel |
| Correspondent | William J Engel DEL MEDICAL IMAGING CORP. 11550 WEST KING ST. Franklin Park, IL 60131 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-10-20 |
| Decision Date | 2006-11-30 |
| Summary: | summary |