Emageon, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
Catalogue
Heartsuite Hemodynamics 7.10 Ref K082421
Regimes: 510(k) Registry: 510(k)Evms (Enterprise Visual Medical System Software) Ref K053281
Regimes: 510(k) Registry: 510(k)
FDA recalls
2008
- 1 Jan 2008 Z-1644-2008 Unclassified (pre-2012) Terminated Miscalculation: The calculation of the standard uptake value does not include the required calibration factor/decay correction factor. The resulting value is incorrectly calculated, which may lead to incorrect interpretation of tissue density. The calculation error exists in both the software and user guide.
Full distribution text
- 1 Jan 2008 Z-1644-2008 Unclassified (pre-2012) Terminated Miscalculation: The calculation of the standard uptake value does not include the required calibration factor/decay correction factor. The resulting value is incorrectly calculated, which may lead to incorrect interpretation of tissue density. The calculation error exists in both the software and user guide.
Frequently asked questions
How many devices does Emageon, Inc. have in the registry?
The registry currently lists 2 devices for Emageon, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Emageon, Inc.'s devices?
Among its 2 most recently registered devices, Emageon, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Emageon, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Emageon, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Emageon, Inc.?
FDA recall records list 1 recall initiated by Emageon, Inc., the most recent initiated on 1 Jan 2008. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Emageon, Inc. in the registry?
The most recently registered devices listed for Emageon, Inc. include HEARTSUITE HEMODYNAMICS 7.10 and EVMS (ENTERPRISE VISUAL MEDICAL SYSTEM SOFTWARE).