The following data is part of a premarket notification filed by Image Information Systems, Ltd. with the FDA for Iq-system Pacs System.
| Device ID | K062488 |
| 510k Number | K062488 |
| Device Name: | IQ-SYSTEM PACS SYSTEM |
| Classification | System, Image Processing, Radiological |
| Applicant | IMAGE INFORMATION SYSTEMS, LTD. 1600 MANCHESTER WAY Corinth, TX 76210 |
| Contact | Carl Alletto |
| Correspondent | Carl Alletto IMAGE INFORMATION SYSTEMS, LTD. 1600 MANCHESTER WAY Corinth, TX 76210 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-25 |
| Decision Date | 2006-09-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B403IQS150 | K062488 | 000 |
| B403IQS140 | K062488 | 000 |
| B403IQS130 | K062488 | 000 |
| B403IQS120 | K062488 | 000 |
| B403IQS160 | K062488 | 000 |
| B403IQS170 | K062488 | 000 |
| B403IQS190 | K062488 | 000 |