The following data is part of a premarket notification filed by Impact Systems Corp. with the FDA for Interface Modules Im 1000 Image Communi-network.
| Device ID | K850417 |
| 510k Number | K850417 |
| Device Name: | INTERFACE MODULES IM 1000 IMAGE COMMUNI-NETWORK |
| Classification | System, Digital Image Communications, Radiological |
| Applicant | IMPACT SYSTEMS CORP. 2448 SOUTH 102ND. SUITE 325 Milwaukee, WI 53227 |
| Contact | William C Mortimore |
| Correspondent | William C Mortimore IMPACT SYSTEMS CORP. 2448 SOUTH 102ND. SUITE 325 Milwaukee, WI 53227 |
| Product Code | LMD |
| CFR Regulation Number | 892.2020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-02-04 |
| Decision Date | 1985-10-16 |