The following data is part of a premarket notification filed by Sterling Diagnostic Imaging, Inc. with the FDA for Iirad Directray Operator Console.
| Device ID | K980970 |
| 510k Number | K980970 |
| Device Name: | IIRAD DIRECTRAY OPERATOR CONSOLE |
| Classification | System, Image Processing, Radiological |
| Applicant | STERLING DIAGNOSTIC IMAGING, INC. 10 SOUTH ACADEMY ST. MAIL DROP 120 Greenville, SC 29601 |
| Contact | Jean E Bartlett |
| Correspondent | Jean E Bartlett STERLING DIAGNOSTIC IMAGING, INC. 10 SOUTH ACADEMY ST. MAIL DROP 120 Greenville, SC 29601 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-03-16 |
| Decision Date | 1998-06-08 |
| Summary: | summary |