intelerad.comHEALTHVIEW ECG MANAGER
LUMEDX
LUMEDX
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3008012314 | 3008012314 | LUMEDX | 1 | N | 2026-01-01 | 305 Church at N Hills St 6th Floor Raleigh NC US 27609 |
| 3008012314 | 3008012314 | LUMEDX | 1 | Y | 2020-04-25 | 110 110th Ave NE Ste 475 Bellevue WA US 98004 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00857560008003 | HealthView CardioPACS - CardioPACS is a software device intended to be used by medical professionals for storage, review, query/ retrieve, analysis, and post processing of DICOM medical images that are generated by echocardiography, radiology, and other modalities. The device can be used as a stand-alone product or in a networked system. CardioPACS is not intended for use with mammograms. | 801-891-4570 | regulatory-affairs@intelerad.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 108311 | 1142540467 | K123466 | HEALTHVIEW ECG MANAGER | DQK | 2012-12-20 |
| 299353 | 1496889099 | K123466 | HEALTHVIEW ECG MANAGER | DQK | 2012-12-20 |
| 108311 | 1304594252 | K120514 | CARDIOPACS | LLZ | 2012-07-05 |
| 299353 | 1601373711 | K120514 | CARDIOPACS | LLZ | 2012-07-05 |
| 108311 | 1360423272 | K041581 | COMPACS, VERSION 1.0 | LLZ | 2004-06-22 |
| 108311 | 1537786897 |
Product Codes Associated With Registrations#
PMN#
CARDIOPACS
LUMEDX
GUDID#
HealthView CardioPACS - CardioPACS is a software device intended to be used by medical professionals for storage, review, query/ retrieve, analysis, and post processing of DICOM medical images that are generated by echocardiography, radiology, and other modalities. The device can be used as a stand-alone product or in a networked system. CardioPACS is not intended for use with mammograms.
2018-08-13
HealthView ECG Manager - The HealthView ECG Manager is a computer system, used within a clinical network, which is intended to be used by trained professionals. It provides the ability to retrieve, store, edit, send, and print ECGs and related digitized clinical documents through the use of on-screen measurement and editing tools. The system receives files (such as ECG, Stress, Holter, or PFT) from any compatible device, displaying such data to the clinician for analysis and review. The product does not modify the original ECG waveform and does not provide an automated ECG analysis.
2018-11-30