The following data is part of a premarket notification filed by Sterling Diagnostic Imaging, Inc. with the FDA for Iisys Pacs System.
| Device ID | K980220 |
| 510k Number | K980220 |
| Device Name: | IISYS PACS SYSTEM |
| Classification | System, Digital Image Communications, Radiological |
| Applicant | STERLING DIAGNOSTIC IMAGING, INC. 10 SOUTH ACADEMY ST. MAIL DROP 120 Greenville, SC 29601 |
| Contact | Timothy W Capehart |
| Correspondent | Timothy W Capehart STERLING DIAGNOSTIC IMAGING, INC. 10 SOUTH ACADEMY ST. MAIL DROP 120 Greenville, SC 29601 |
| Product Code | LMD |
| CFR Regulation Number | 892.2020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-01-22 |
| Decision Date | 1998-02-13 |
| Summary: | summary |