510(k) K051087 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
DIMENSION VISTA INTEGRATED SYSTEM
| Applicant | Dade Behring, Inc., Newark DE, US |
| Decision | Substantially Equivalent, Jul 11, 2005 |
| Received | Apr 28, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K051087
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 15, 2021 | Siemens Healthcare Diagnostics, Inc. Dimension Vista 1500 In-vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of anal Terminated |
JJE | None listed |
| Oct 15, 2021 | Siemens Healthcare Diagnostics, Inc. Dimension Vista 500- In-vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of anal Terminated |
JJE | None listed |
| Dec 12, 2018 | Siemens Healthcare Diagnostics, Inc. Dimension Vista 500, Analyzer, chemistry Model no. 10284473 Terminated |
JJE | None listed |
| Oct 16, 2018 | Siemens Healthcare Diagnostics, Inc. Dimension Vista 500, model no. 10284473 an in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to deter Terminated |
JJE | None listed |
| Mar 19, 2017 | Siemens Healthcare Diagnostics, Inc. Dimension Vista 500 Intelligent Lab System and Dimension Vista 1500 Intelligent Lab System, analyzer, chemistry (photometric, discrete), for clinical use
Product Usage:
The Siemens Healthcare Diagnos Terminated |
JJE | None listed |
| Jun 1, 2016 | Siemens Healthcare Diagnostics Inc. Dimension Vista 500 Intelligent Lab System running on software versions V.3.6.1 SP1 or V.3.6.2, Device listing # D011374, All serial numbers and lots are affected.
The Dimension Vista System is an in Terminated |
JJE | None listed |
| Jun 1, 2016 | Siemens Healthcare Diagnostics Inc. Dimension Vista 1500 Intelligent Lab System running on software versions V.3.6.1 SP1 or V.3.6.2, Device listing # D011374, All serial numbers and lots are affected.
The Dimension Vista System is an i Terminated |
JJE | None listed |
| Feb 16, 2016 | Siemens Healthcare Diagnostics, Inc. Dimension Vista Blood Urea Nitrogen (BUN) Flex reagent cartridge
The BUN method is an in vitro diagnostic test for the quantitative measurement of urea nitrogen (an end product of nitrogen metabolism Terminated |
CDQ | None listed |
| Jul 9, 2015 | Siemens Healthcare Diagnostics, Inc. Siemens Healthcare Diagnostics Dimension Vista Systems, used with the Dimension Vista Intelligent Lab System software version 3.6.1. In vitro diagnostic analyzer. Terminated |
JJE | None listed |
| Dec 20, 2014 | Siemens Healthcare Diagnostics, Inc. Dimension Vista 500 Intelligent Lab System or Dimension Vista 1500 Intelligent Lab System:
An in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, Terminated |
JJE | None listed |
| Oct 6, 2014 | Siemens Healthcare Diagnostics, Inc. Dimension Vista Mass CKMB Isoenzyme Calibrator (MMB CAL) an in vitro diagnostic product for the calibration of Creatine Kinase MB Isoenzyme (MMB) method on the Dimension Vista System. Terminated |
JIT | None listed |
| Jun 9, 2014 | Siemens Healthcare Diagnostics, Inc. Siemens Healthcare Diagnostics Vista Air Compressor.
Vista AirCompressor replacement part: SMN 10706557 SKIT Air Compressor Assy, used on the Dimension Vista 500 and Dimension Vista 1500 systems.
Terminated |
JJE | None listed |
| Jan 28, 2014 | Siemens Healthcare Diagnostics, Inc. User Defined Method Flex Assignment/Siemens Dimension Vista 500 or Dimension Vista 1500 System with software version 3.5.1 or lower
User Defined Method Flex Assignment/Siemens Dimension Vista 500 or Terminated |
JJE | None listed |
| Dec 2, 2013 | Siemens Healthcare Diagnostics, Inc. Dimension Vista(R) 500 and Dimension Vista(R) 1500 - Reloaded Vista Vials - limited to systems using software versions 3.4 and 3.5.1.
Diagnostic device intended to determine a variety of analytes in Terminated |
JJE | None listed |
| Aug 26, 2013 | Siemens Healthcare Diagnostics, Inc. Dimension Vista 500 and Dimension Vista 1500 System Aliquot Well Double Dispense with software versions 3.5.1 and 3.6.
In vitro diagnostic device intended to duplicate manual analytical procedures Terminated |
JJE | None listed |
| Apr 25, 2012 | Siemens Healthcare Diagnostics, Inc. Siemens Healthcare Diagnostics Dimension Vista(R) software version 3.4
The Dimension Vista(R) System is an in vitro diagnostic device intended to duplicate manual analytical procedures such as pipett Terminated |
JJE | None listed |
| Jan 11, 2012 | Siemens Healthcare Diagnostics, Inc. Dimension(R) Vista(R) V-LYTE(R) Standard A (K820)
Product Usage: V-LYTE(R) Standard A is for the calibration of NA, K, and CL on the Dimension Vista(R) system Terminated |
JJE | None listed |
| Jan 11, 2012 | Siemens Healthcare Diagnostics, Inc. Dimension(R) Vista(R) V-LYTE(R) Standard B/Salt Bridge (K825)
Product Usage: V-LYTE(R) Standard B/Salt Bridge is for the calibration and measurement of NA, K, and CL on the Dimension Vista(R) system Terminated |
JJE | None listed |
| Jan 11, 2012 | Siemens Healthcare Diagnostics, Inc. Dimension(R) Vista(R) V-LYTE(R) Diluent (K835)
Product Usage: V-LYTE(R) Diluent is for the automatic dilution of samples processed in the V-LYTE(R) Integrated Multisensor on the Dimension Vista(R) s Terminated |
JJE | None listed |
| Oct 7, 2011 | Siemens Healthcare Diagnostics, Inc. Dimension Vista(R) Cuvettes
The Dimension Vista(R) Cuvettes are for use on the Dimension Vista(R) System. The Dimension Vista(R) integrated system is an in vitro diagnostic device intended to duplic Terminated |
JJE | None listed |
| Oct 25, 2010 | Siemens Healthcare Diagnostics, Inc. Dimension Vista V-LYTE Standard A, Catalog No K820
For the calibration of Na+/K+/Cl- on the Dimension vista System. Terminated |
CEM | None listed |
| Oct 21, 2010 | Siemens Healthcare Diagnostics, Inc. EasyLink Informatics Systems QCFIRST Custom Rule
The EasyLink Informatics System is classified as a data calculator and processing module for use with In-vitro diagnostic devices. The EasyLink is incl Terminated |
JJE | None listed |
| Sep 15, 2010 | Siemens Healthcare Diagnostics, Inc. Siemens Healthcare Diagnostics, Inc., Dimension Vista Intelligent Laboratory System with Alpha Pinnacle 10kVA UPS External Battery Pack. Part numbers: 070200001, 070200011, 070200021; Dimension Vista Terminated |
JJE | None listed |
| Aug 2, 2010 | Siemens Healthcare Diagnostics, Inc. Siemens Healthcare Diagnostics, Dimension Vista LOCI Reaction Vessels, catalog number KS855. For in vitro diagnostic use. Terminated |
JJE | None listed |
| Mar 24, 2010 | Siemens Healthcare Diagnostics, Inc. Dimension Vista System StreamLAB Analytical Workcell. Dimension Vista System Part Numbers 1000035896, 1000035899, 1000036563, and 1000036567. StreamLAB Analytical Workcell Part Number 746002.901, for Terminated |
CDT | None listed |
| Mar 10, 2010 | Siemens Healthcare Diagnostics, Inc. Dimension Vista V-LYTE Fluids: Standard A catalog number K820 Terminated |
JJE | None listed |
| Mar 10, 2010 | Siemens Healthcare Diagnostics, Inc. Dimension Vista V-LYTE Fluids: Standard B/Salt Bridge catalog number K825 Terminated |
JJE | None listed |
| Mar 10, 2010 | Siemens Healthcare Diagnostics, Inc. Dimension Vista V-LYTE Fluids: Diluent catalog number K835 Terminated |
JJE | None listed |
| Mar 8, 2010 | Siemens Healthcare Diagnostics, Inc. Dimension Vista System BUN Flex Reagent Cartridge, Catalog number K1021, in vitro diagnostic. Terminated |
JJE | None listed |
| Mar 5, 2010 | Siemens Healthcare Diagnostics, Inc. Dimension Vista LOCI Reaction Vessel Terminated |
JJE | None listed |
| Sep 29, 2009 | Siemens Healthcare Diagnostics, Inc. EasyLink Informatics System included with the Dimension Vista System.
The Dimension Vista Integrated System is an in vitro diagnostic device intended to duplicate manual analytical procedures such as Terminated |
JJE | None listed |
| Aug 22, 2007 | Dade Behring, Inc. EasyLink Informatics System, software version 3.0, Part Number 1000034941, DADE BEHRING INC., Newark, DE. Terminated |
JJE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.