The following data is part of a premarket notification filed by Standard Imaging, Inc. with the FDA for Standard Imaging Pipspro Qa Software System.
| Device ID | K042733 |
| 510k Number | K042733 |
| Device Name: | STANDARD IMAGING PIPSPRO QA SOFTWARE SYSTEM |
| Classification | Instrument, Quality-assurance, Radiologic |
| Applicant | STANDARD IMAGING, INC. 7601 MURPHY DR. Middleton, WI 53562 -2766 |
| Contact | Raymond Riddle |
| Correspondent | Raymond Riddle STANDARD IMAGING, INC. 7601 MURPHY DR. Middleton, WI 53562 -2766 |
| Product Code | LHO |
| Subsequent Product Code | IXG |
| Subsequent Product Code | IYE |
| Subsequent Product Code | LLZ |
| Subsequent Product Code | LMB |
| Subsequent Product Code | LMD |
| CFR Regulation Number | 892.1940 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-10-01 |
| Decision Date | 2004-11-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00866562000236 | K042733 | 000 |