The following data is part of a premarket notification filed by Sterling Diagnostic Imaging, Inc. with the FDA for Helios Laser Imager 1417.
| Device ID | K973028 |
| 510k Number | K973028 |
| Device Name: | HELIOS LASER IMAGER 1417 |
| Classification | Camera, Multi Format, Radiological |
| Applicant | STERLING DIAGNOSTIC IMAGING, INC. 10 SOUTH ACADEMY ST. Greenville, SC 29601 |
| Contact | Timothy W Capehart |
| Correspondent | Timothy W Capehart STERLING DIAGNOSTIC IMAGING, INC. 10 SOUTH ACADEMY ST. Greenville, SC 29601 |
| Product Code | LMC |
| CFR Regulation Number | 892.2040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-08-14 |
| Decision Date | 1997-10-28 |
| Summary: | summary |