Product code NSX
NSX
0510(k)s in 12 months (0 all time)
0recalls in 12 months (28 all time)
2recalls that name a 510(k)
Top companies in NSX
| Company | 510(k)s | Recalls |
|---|---|---|
| Roche Molecular Systems, Inc. | 0 | 10 |
| Picis Inc. | 0 | 6 |
| Siemens Healthcare Diagnostics, Inc. | 0 | 3 |
| Soft Computer Consultants, Inc. | 0 | 3 |
| Baxter Healthcare Corp. | 0 | 1 |
| BD LIFE SCIENCES | 0 | 1 |
| bioMerieux, Inc. | 0 | 1 |
| Cisco Systems Inc | 0 | 1 |
| Merge Healthcare, Inc. | 0 | 1 |
| Philips Healthcare Inc. | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 13, 2022 | bioMerieux, Inc. VITEK 2 / MYLA
VITEK 2 Software versions 8.01, 8.02 (veterinary use only), 9.01, 9.02, 9.03
MYLA Software versions V4.8 and V4.9 Open, Classified |
NSX | None listed |
| May 31, 2017 | Soft Computer Consultants, Inc. SoftLab Software
Laboratory information system to be used in a medical research or clinical laboratory by knowledgeable, trained, Terminated |
NSX | None listed |
| Apr 4, 2017 | BD LIFE SCIENCES Software version 4.44A utilized on the BD MAX System Terminated |
NSX | K111860 |
| Jan 23, 2017 | Merge Healthcare, Inc. Merge LIS Terminated |
NSX | None listed |
| Oct 6, 2016 | Soft Computer Consultants, Inc. Softbank software
Product Usage:
Decision support software for transfusion service. It keeps track of inventory from outside sources, multi-site inventory control, records of testing of units, and al Terminated |
NSX | None listed |
| Oct 6, 2016 | Soft Computer Consultants, Inc. SCC Soft Computer Softbank II software
Product Usage:
Supports single and multi-site transfusion services in healthcare facilities. Used by healthcare personal to document, query, and view the integr Terminated |
NSX | None listed |
| Dec 3, 2013 | Siemens Healthcare Diagnostics, Inc. syngo(R) Lab Data Manager - Version VA11B and VA12A Systems
Securely consolidates data from multiple lab instruments, the LIS and Siemens StreamLAB(R) Automation Solutions. It provides autoverificati Terminated |
NSX | None listed |
| Jul 29, 2013 | Picis Inc. Picis ED Pulsecheck - EMR Software Application - 2125, Software Versions: 5.2 and 5.3. The application stores patient information in a database, and it may analyze and/or display the data in differen Terminated |
NSX | None listed |
| Dec 7, 2012 | Roche Molecular Systems, Inc. DataCare POC is an information management system that provides data management functionality for managing point-of -care testing data. Terminated |
NSX | None listed |
| Dec 7, 2012 | Roche Molecular Systems, Inc. DataCara GM is an information management system that provides data management functionality for managing blood glucose testing data. Terminated |
NSX | None listed |
| Dec 7, 2012 | Roche Molecular Systems, Inc. DataInnovations (Instrument Manager) (version 8.04) interfaces middleware between larger Clinical Chemistry / Immunology instrument systems and LIS systems. Terminated |
NSX | None listed |
| Dec 7, 2012 | Roche Molecular Systems, Inc. The COBAS INTEGRA 400/400 plus system (software version 3.4) is a fully automated, computerized chemistry analyzer. It is intended for in vitro quantitative or qualitative determination of a wide rang Terminated |
NSX | None listed |
| Dec 7, 2012 | Roche Molecular Systems, Inc. The COBAS 8000 data manager modular analyzer series (all versions) is a is a fully automated, random-access, software- controlled system for immunoassay and photometric analysis intended for qualita Terminated |
NSX | None listed |
| Dec 7, 2012 | Roche Molecular Systems, Inc. LightCycler 2.0 Instrument (software version 4.1) is a Rapid PCR analyzer with real-time detection and/or quantification of a target NA (nucleic acid), as well as post-PCR analysis of the amplified NA Terminated |
NSX | None listed |
| Dec 7, 2012 | Roche Molecular Systems, Inc. LightCycler 1.2 (software version 3.5) is a Rapid PCR analyzer with real-time detection and/or quantification of a target NA (nucleic acid), as well as post-PCR analysis of the amplified NA by melting Terminated |
NSX | None listed |
| Dec 7, 2012 | Roche Molecular Systems, Inc. The MagNA Pure 96 System (versions 1.0 and 2.0) is a sample preparation instrument for automated isolation of nucleic acids in various types of biological materials. This is a general purpose instr Terminated |
NSX | None listed |
| Dec 7, 2012 | Roche Molecular Systems, Inc. The MagNA Pure LC (version 3.0) is a sample preparation instrument that can be used with the LightCycler instrument for automated isolation of nucleic acids in various types of biological materials. Terminated |
NSX | None listed |
| Dec 7, 2012 | Roche Molecular Systems, Inc. Data Station AMPLILINK software is an instrument user interface/ data management software used with COBAS AmpliPrep instrument, COBAS TaqMan analyzer, COBAS TaqMan 48 analyzer, COBAS AMPLICOR analyzer Terminated |
NSX | None listed |
| Aug 24, 2012 | Cisco Systems Inc Cisco brand HealthPresence, version 2.1; Model/Catalog Number: CHP-ENTPRSYR2.I-K9; Product is manufactured and distributed by Cisco Systems, Inc. San Jose, CA
Cisco HealthPresence, version 2 is inten Terminated |
NSX | None listed |
| Aug 9, 2012 | Siemens Healthcare Diagnostics, Inc. EasyLink(TM) Informatics System, Part Number 1000034805. EasyLink(TM) Informatics System is classified as a data calculator and processing module for use with In-Vitro diagnostics devices. Terminated |
NSX | None listed |
| Aug 9, 2012 | Siemens Healthcare Diagnostics, Inc. Siemens syngo(R) Lab Data Manager.
The syngo(R) Lab Data Manager is classified as a data calculator and processing module for use with In-vitro diagnostic devices. It also provides work flow manageme Terminated |
NSX | None listed |
| Oct 31, 2011 | Picis Inc. Picis Anesthesia Manager, PACU Manager,Critical Care Manager-8.2 Service Pack 4 or higher
(Software, transmission & storage, patient data)
This product is a non-alarming software patient information Terminated |
NSX | None listed |
| Sep 23, 2011 | Picis Inc. CareSuite" - Critical Care Manager, PACU Manager and Anesthesia Manager Software, transmission & storage, patient data.
This product is a non-alarming software patient information system that compile Terminated |
NSX | None listed |
| Sep 7, 2011 | Picis Inc. Picis ED PulseCheck-Software, transmission & storage, patient data
Service Pack v5.0 L and M
This product is a non-alarming software patient information system that compiles an electronic medical re Terminated |
NSX | None listed |
| May 10, 2011 | Philips Healthcare Inc. Philips IntelliVue Clinical Information Portfolio software as follows:
865047 IntelliVue Clinical Information Portfolio Release D.03; 865209 IntelliVue Clinical Information Portfolio Release E.0 and E Terminated |
NSX | K100272 K992636 |
| Apr 6, 2010 | Picis Inc. CareSuite" - Critical Care Manager, PACU Manager and Anesthesia Manager
Software: CareSuite 5.1 and later Terminated |
NSX | None listed |
| Nov 18, 2009 | Picis Inc. PICIS, CareSuite Family- OR Manager (4235), Preop Manager (4250), Anesthesia Manager (4220), PACU Manager (4245) & Critical Care Manager (1110), patient information systems. Terminated |
NSX | None listed |
| Oct 8, 2005 | Baxter Healthcare Corp. Baxter''s Patient Care System (BPCS) software, composed of Pharmacy Management - Inpatient - product code 2M5013, Point of Care - product code 2M5014 and Management Reports - product code 2M5015; Baxt Terminated |
NSX | None listed |
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