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Instrument Manager is a stand-alone software application that provides connectivity between laboratory instruments and Laboratory Information Systems, aiding the flow of laboratory information, including test orders and results, specimen information, and patient information. Instrument Manager also provides data management functions that aid in the interpretation and management of laboratory results. Instrument Manager is a software package intended to be used by trained laboratory personnel as an aid in laboratory instrument interfacing and laboratory data management.
DATA INNOVATIONS LLC
8141101
Not in Commercial Distribution
- B180IMB028140 ()
IMB02814
- Clinical laboratory information system application software
CTB software versions 2.3+
Annalise Critical Care AI is a medical device software application which uses artificial intelligence (AI) algorithms to prioritize suggested findings within a clinical triage workflow of radiological imaging studies.
ANNALISE-AI PTY LTD
2.3+
In Commercial Distribution
- G140ANNALISECONTAINER70 ()
Annalisecontainer7
- Radiology DICOM image processing application software
Spaulding Client Application is a web based application for trained users of the Spaulding Medical Electrocardiograph device 2100iQ.
The application enables clinicians or trained core personnel who are acting on the orders of a licensed physician to process, display, store, and print diagnostic 12 lead ECGs utilizing a Windows platform.
SPAULDING MEDICAL
3.0.6.1
In Commercial Distribution
- B441SMWINCLIENTAPP0 ()
SMWINCLIENTAPP
- Electrocardiographic long-term ambulatory recording analyser application software
Spaulding Client Application is a web based application for trained users of the Spaulding Medical Electrocardiograph device 2100iQ.
The application enables clinicians or trained core personnel who are acting on the orders of a licensed physician to process, display, store, and print diagnostic 12 lead ECGs utilizing an IOS platform.
SPAULDING MEDICAL
1.3.6.1
In Commercial Distribution
- B441SMIOSCLIENTAPP0 ()
SMIOSCLIENTAPP
- Electrocardiographic long-term ambulatory recording analyser application software
Spaulding Client Application is a web based application for trained users of the Spaulding Medical Electrocardiograph device 2100iQ.
The application enables clinicians or trained core personnel who are acting on the orders of a licensed physician to process, display, store, and print diagnostic 12 lead ECGs utilizing an Android platform.
SPAULDING MEDICAL
1.2.6.1
In Commercial Distribution
- B441SMANDCLIENTAPP0 ()
SMANDCLIENTAPP
- Electrocardiographic long-term ambulatory recording analyser application software
The Fitbit Irregular Rhythm Notifications is a software-only mobile medical application that is intended to be used with compatible consumer wrist-worn products to analyze pulse rate data to identify episodes of irregular heart rhythms suggestive of atrial fibrillation (AFib) and provide a notification to the user.
The Fitbit Irregular Rhythm Notifications is intended for over-the-counter (OTC) use. It is not intended to provide a notification on every episode of irregular rhythm suggestive of AFib and the absence of a notification is not intended to indicate no disease process is present; rather the Fitbit Irregular Rhythm Notifications is intended to opportunistically surface a notification of possible AFib when sufficient data are available for analysis.
These data are only captured when the user is still. Along with the user’s risk factors, the Fitbit Irregular Rhythm Notifications can be used to supplement the decision for AFib screening. The Fitbit Irregular Rhythm Notifications is not intended to replace traditional methods of diagnosis or treatment.
The Fitbit Irregular Rhythm Notifications has not been tested for and is not intended for use
in people under 22 years of age. It is also not intended for use in individuals previously
diagnosed with AFib.
FITBIT, INC.
FB604
In Commercial Distribution
- 00810038852720 ()
FB604
- Cardiopulmonary physiological parameter analysis software
No Description
SCC SOFT COMPUTER
25.6.1.2
In Commercial Distribution
- 00810055815647 ()
- Blood bank information system application software
No Description
SCC SOFT COMPUTER
1.0.0.20
In Commercial Distribution
- 00810055815302 ()
- Bedside information system application software
No Description
SCC SOFT COMPUTER
25.5.6.4
In Commercial Distribution
- 00810055814503 ()
- Blood bank information system application software
No Description
SCC SOFT COMPUTER
4.5.5.1
In Commercial Distribution
- 00810055814152 ()
- Blood bank information system application software