Company
Ge Healthcare It
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
25recalls (0 in 12 months)
13recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 6, 2016 | Ge Healthcare It Centricity Enterprise Archive is a software product for receiving, archiving and sending of medical data. Qualified system administrators install, monitor and maintain the system. DICOM devices (e.g. Terminated |
LMB | None listed |
| Dec 19, 2014 | Ge Healthcare It Centricity Enterprise Archive is a software product for receiving, archiving and sending of medical data. DICOM devices (e..g. modalities, workstations) Communicate with the archive using the DICOM pr Terminated |
LMB | None listed |
| Jan 29, 2014 | GE Healthcare It The Centricity Laboratory System is intended to be an information system designed to support the clinical and administrative activities associated with the provision and utilization of clinical labora Terminated |
JQP | None listed |
| Jan 15, 2014 | Ge Healthcare It Imagecast PACS is an image management system intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians. The system is used with general purp Terminated |
LLZ | K052618 |
| Jan 14, 2014 | GE Healthcare It Merge Mammo is a multi-modality, vendor-neutral digital mammography workstation that enables imaging centers to use a single workstation to display and read images from different vendors and different Terminated |
LLZ | K040468 |
| Jan 14, 2014 | Ge Healthcare It Centricity PACS System versions 3.X and higher and 4.X and higher
Product Usage: The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by Terminated |
LLZ | K043415 |
| Jan 2, 2014 | GE Healthcare It The Centricity Laboratory System is intended to be an information system designed to support the clinical and administrative activities associated with the provision and utilization of clinical labora Terminated |
JQP | None listed |
| Dec 5, 2013 | Ge Healthcare It The GE Centricity Web; Software Version 3.0x, is intended for use under the direct supervision of a licensed healthcare practitioner. The Centricity Enterprise Web is an image and information distribu Terminated |
LMD | None listed |
| Nov 18, 2013 | GE Healthcare It Centricity Perinatal and Centricity Intensive Care is intended to be used in clinical departments healthcare delivery systems such as a Labor and Delivery, Postpartum Maternal Care, newborn Nursery, c Terminated |
HGM | K111614 |
| Nov 15, 2013 | GE Healthcare It The Centricity Laboratory System is intended to be an information system designed to support the clinical and administrative activities associated with the provision and utilization of clinical labora Terminated |
JQP | None listed |
| Oct 30, 2013 | GE Healthcare It The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals, including radiologists, physicians, technologis Terminated |
LLZ | K043415 |
| Oct 30, 2013 | Ge Healthcare It Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, comm Terminated |
LLZ | K083018 |
| Oct 21, 2013 | GE Healthcare It Centricity Cardio Imaging 5.0 is a software only Picture Archiving and Communication System (PACS).
Product Usage: It will be sold as a software only device to operate on general purpose computing Terminated |
LLZ | K112570 |
| Jun 24, 2013 | GE Healthcare It The Centricity Laboratory System is intended to be an information system designed to support the clinical and administrative activities associated with the provision and utilization of clinical labora Terminated |
JQP | None listed |
| Feb 18, 2013 | Ge Healthcare It Imagecast PACS with Centricity RIS-IC versions prior to 10.6 Update Package 18
Product Usage: is an image management system intended to be used by trained professionals, including but not limited to Terminated |
LLZ | K052618 |
| Nov 20, 2012 | GE Healthcare It Centricity Laboratory Core Lab System 4.1
The Centricity Laboratory System is intended to be an information system designed to support the clinical and administrative activities associated with the p Terminated |
JQP | None listed |
| Nov 15, 2012 | GE Healthcare It GE Centricity PACS Workstation, versions 3.1.1.x through 3.2.1.x Picture Archiving and Communication System
Used as a primary diagnostic and analysis tool for diagnostic images by trained healthcar Terminated |
LLZ | K043415 |
| Jun 14, 2011 | Ge Healthcare It GE Centricity Laboratory Instrument Interface to Data Innovations Instrument Manager software; GE Healthcare IT Solutions, Barrington, IL 60010.
The Centricity Laboratory is designed to facilitate t Terminated |
JQP | None listed |
| Feb 15, 2011 | Ge Healthcare It GE Centricity Laboratory software; GE Healthcare IT, Barrington, IL 60010. The intended use: the Centricity Laboratory is used to facilitate the general clinical, anatomic pathology and cytology labor Terminated |
JQP | None listed |
| Oct 22, 2010 | Ge Healthcare It GE Centricity Laboratory Instrument Interface software; GE Healthcare Integrated IT Solutions, Barrington, IL 60010. The intended use: the Centricity Laboratory is used to facilitate the general clini Terminated |
JQP | None listed |
| May 26, 2010 | Ge Healthcare It GE Centricity Laboratory software; GE Healthcare Integrated IT Solutions, Barrington, IL 60010. The intended use: the Centricity Laboratory is used to facilitate the general clinical, anatomic patholo Terminated |
JQP | None listed |
| Apr 16, 2010 | Ge Healthcare It GE Centricity Web Diagnostic (WebDX) software; GE Healthcare Integrated IT Solutions, Barrington, IL 60010.
Device that receives, stores and communicates medical images and data from various imaging Terminated |
LLZ | K083018 |
| Apr 16, 2010 | Ge Healthcare It GE Centricity PACS-IW software; GE Healthcare Integrated IT Solutions, Barrington, IL 60010.
Device that receives, stores and communicates medical images and data from various imaging sources. Terminated |
LLZ | K082318 |
| Apr 15, 2010 | Ge Healthcare It GE Centricity Web Diagnostic 1.0(WebDX) software; GE Healthcare Integrated IT Solutions, Barrington, IL 60010.
The Intended use:The Centricity PACS-IW is used to receive medical images (including ma Terminated |
LLZ | K083018 |
| Apr 15, 2010 | Ge Healthcare It GE Centricity PACS-IW software; GE Healthcare Integrated IT Solutions, Barrington, IL 60010.
The intended use:The Centricity PACS-IW is used to receive medical images (including mammograms) and data Terminated |
LLZ | K082318 |