# K063628: Centricity Radiology RA600, Cardiology CA1000 and Digital Hardcopy

- Pathway: 510(k) (Traditional)
- Applicant: Ge Healthcare Integrated IT Solutions
- Decided: Dec 26, 2006 after 20 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K842308 (1984). 16 ancestors in all.
18 later devices descend from it; 3 cite it directly.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042525: Centricity Radiology RA600/Centricity Cardiology CA1000/Centricity Digital Hardcopy Workstation, Ge Medical Systems Information Technologies (2004) Summary page 1.
- K023178: Innova 4100, Ge Medical Systems, Inc. (2002) Summary page 1.
- K023100: Accusketch Cardiac Quantitative System W/ Advanced Analysis Components, General Electric Medical Systems Information Techn (2002) Summary page 1.

## Most influential descendants
- K081018: Syngo Dynamics Version 7.0 (2008), 8 descendants of its own
- K102150: Syngo Dynamics, Version 9.0 (2010), 7 descendants of its own
- K123922: Syngo Dynamics (2013), 5 descendants of its own
- K171053: syngo Dynamics Version VA30 (2017), 4 descendants of its own
- K081630: Mammo Workstation (2008), 4 descendants of its own

## Recalls of this device
- Feb 19, 2025 · Class II · Z-1485-2025: There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-IW (PACS-IW), Centricity Radiology RA600 (RA600), & Centricity Cardiology CA1000 (CA1000) where the ser
- Feb 19, 2025 · Class II · Z-1486-2025: There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-IW (PACS-IW), Centricity Radiology RA600 (RA600), & Centricity Cardiology CA1000 (CA1000) where the ser
- Apr 28, 2022 · Class II · Z-1231-2022: Potential for Distance and Area measurements to display inaccurate measurement values when performed on magnified images, and specific to ZFP, Distance and Area measurements can display inaccurate mea

## Indications for use
RA600/CA1000/Digital Hardcopy is intended for viewing and diagnostic interpretation of images acquired from CT, MR, CR, DR, US, XA and other DICOM-compliant medical imaging systems when installed on suitable commercial-standard PC hardware. RA600 / CA1000 is intended for use as a primary diagnostic and analysis workstation in Radiology/ Cardiology or other departments. It is also intended for use as a clinical review workstation throughout the healthcare facility and may be part of a larger PACS configuration. Digital Hardcopy is intended for use primarily as a workstation for the high volume burning of CDs or DVDs containing DICOM medical images and associated diagnostic report or analysis information. CD /DVD burning and disk labeling are done via a commercially available external robotics device. RA600/CA1000/Digital Hardcopy receives imaging studies and data over LAN, WAN, intranet or internet from a PACS server or directly from a DICOM -compliant modality or archive utilizing both lossless and lossy compression. It is the user's responsibility to ensure quality, ambient light conditions and image compression ratios are consistent with the clinical application. The RA600/CA1000/Digital Hardcopy workstation may interface with various information systems within the healthcare environment, such as the HIS, RIS, and CVIS. It may be sold as software only, or as a turnkey system Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.

Source page: https://510kreport.com/device/K063628
Methodology: https://510kreport.com/methodology