The following data is part of a premarket notification filed by Dr. Systems, Inc. with the FDA for Dr Systems Pacs, Release 6.1.
| Device ID | K041935 |
| 510k Number | K041935 |
| Device Name: | DR SYSTEMS PACS, RELEASE 6.1 |
| Classification | System, Image Processing, Radiological |
| Applicant | DR. SYSTEMS, INC. 10140 MESA RIM RD. San Diego, CA 92121 |
| Contact | Kimberly J Meade |
| Correspondent | Kimberly J Meade DR. SYSTEMS, INC. 10140 MESA RIM RD. San Diego, CA 92121 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-07-19 |
| Decision Date | 2004-08-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842000100744 | K041935 | 000 |
| 00842000100331 | K041935 | 000 |
| 00842000100058 | K041935 | 000 |
| 00842000100461 | K041935 | 000 |
| 00842000100829 | K041935 | 000 |