CARDIOPACS
System, Image Processing, Radiological
LUMEDX
The following data is part of a premarket notification filed by Lumedx with the FDA for Cardiopacs.
Pre-market Notification Details
| Device ID | K120514 |
| 510k Number | K120514 |
| Device Name: | CARDIOPACS |
| Classification | System, Image Processing, Radiological |
| Applicant | LUMEDX 110, 110TH AVE NE Bellevue, WA 98004 |
| Contact | Chris Pearce |
| Correspondent | Chris Pearce LUMEDX 110, 110TH AVE NE Bellevue, WA 98004 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-02-21 |
| Decision Date | 2012-07-05 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857560008003 | K120514 | 000 |
Trademark Results [CARDIOPACS]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CARDIOPACS 78322874 2979487 Dead/Cancelled |
LUMEDX CORPORATION 2003-11-04 |
 CARDIOPACS 76087456 not registered Dead/Abandoned |
Witt Biomedical Corporation 2000-07-13 |
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