# K020440: Newcor

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Systems, Inc.
- Decided: Dec 3, 2002 after 295 days
- Product code: DQK (Computer, Diagnostic, Programmable)
- Device class: 2
- Regulation: 21 CFR 870.1425
- Recalls of this device: 10 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K910772 (1991). 21 ancestors in all.
9 later devices descend from it; 2 cite it directly.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993414: Prucka Engineering Inc. Cardiolab EP System,Version 4.2, Prucka Engineering, Inc. (2000) Summary page 1.
- K002137: Cathcor Desktop, Siemens Elema AB (2000) Summary page 1.
- K930786: EPCOR, Siemens Medical Solutions USA, Inc. (1994) Summary page 1.
- K982776: 9303 Neonatal/Adult Vital Signs Monitor, Cas Medical Systems, Inc. (1998) Summary page 1.
- K003004: Oscar 2, Model 222, Suntech Medical Instruments, Inc. (2000) Summary page 1.
- K980882: Siemens  SC 7000 & SC 9000 XL Infinity Modular Bedside Monitor, Siemens Medical Solutions USA, Inc. (1998) Summary page 1.

## Most influential descendants
- K101571: Xper Information Management and Flex Cardio Physiomonitoring Systems (2010), 5 descendants of its own
- K131497: Mckesson Cardiology Hemo (2013), 3 descendants of its own
- K131812: Sensis, Sensis Lite (2013), 2 descendants of its own
- K170032: QMAPP Amplifier; QMAPP Hemodynamic Monitoring System; QMAPP PCM; QMAPP GO; QMAPP EP (2017), 1 descendant of its own
- K150493: Sensis (2015), 1 descendant of its own

## Recalls of this device
- May 16, 2017 · Class II · Z-2688-2017: Software error. In Sensis Vibe systems with software version VD10B, a software error can result in: problems generating a report and/ or - information from different examinations of the same patient b
- Apr 12, 2017 · Class II · Z-2156-2017: An extremely dusty computer can cause problems at system start, or rarely, cause system fail. Perform a system check prior to performing exams. If the Sensis system fails, its functions can not be use
- Feb 22, 2012 · Not classified · Z-1506-2012: There is a potential malfunction in the connection of a Sensis EP system with Carto(R) 3 dedicated cable set (part number 14411343) with the Carto 3 system from Bionsense Webster.
- Jul 9, 2004 · Not classified · Z-0032-05: possible error calculating valve area with the AXIOM Sensis
- Jul 9, 2004 · Not classified · Z-0036-05: possible error calculating valve area with the AXIOM Sensis
- Jul 9, 2004 · Not classified · Z-0033-05: possible error calculating valve area with the AXIOM Sensis
- Jul 9, 2004 · Not classified · Z-0034-05: possible error calculating valve area with the AXIOM Sensis
- Jul 9, 2004 · Not classified · Z-0035-05: possible error calculating valve area with the AXIOM Sensis
- May 17, 2004 · Not classified · Z-1446-04: Software issue. Allows for users to enter date in Pre-Cath Holding Area prior to registering the patient in the Cath Lab.
- Feb 28, 2003 · Not classified · Z-0979-03: software problem - erroneous results or system crashes

## Indications for use
The AXIOM Sensis system is intended to be used as a diagnostic and administrative tool supporting hemodynamic cardiac catheterizations and/or intracardiac electrophysiology studies. The system is equipped by modules, enabling various configurations ranging from a stand-alone acquisition unit with limited administrative functionality to multiunit installations with a common database and satellite workstations accessing the data using the administrative tools. The AXIOM Sensis system has functions for: 1. External communication via the DICOM interface by using Siemens Medical Platform syngo and AXIOM Sensis VCOOA DICOM Conformance Statement 2. External Communication via the HL7 interface by using AXIOM Sensis Interface description HL7 Interface. 3. Local communication by using the Siemens HICOR interface 4. Local communication by using the Siemens AXIOM Artis-FC/BC interface 5. Local communication with Medtronic Model 4803, Atakr II RF Power Generator, Boston Scientific EP Technologies EPT-100 TC, and Stockert EP-Shuttle Ablator devices The device is intended to be used on either or both of the following populations: 1. Adult and pediatric populations requiring intracardiac electrophysiology examinations, typically when the patient is suffering from cardiac arrhythmias. 2. Adult and pediatric populations requiring intracardiac hemodynamic examinations, typically when the patient has a heart disease resulting in insufficient hemodynamic functionality.

Source page: https://510kreport.com/device/K020440
Methodology: https://510kreport.com/methodology