510(k) · Cleared
Recalled · Class II · 2025Centricity Radiology RA600, Cardiology CA1000 and Digital Hardcopy
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Healthcare Integrated IT Solutions · LLZ System, Image Processing, Radiological
Cleared on Dec 26, 2006 as substantially equivalent to K042525 (Ge Medical Systems Information Technologies, 2004) and 2 other predicates after a 20-day review. Its family tree reaches back 5 generations to 1984. 18 later devices descend from it. It has been recalled 3 times.
- Decided
- Dec 26, 2006
- Review
- 20 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- 3
- Predicates
- 3
Its longest line of descent runs back 5 generations to K842308 (1984). 16 ancestors in all. 18 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK842308 12SSL-SCMarquette Electronics, Inc. · 1984
- 4 generations backK980495 Muse Cardiovascular Information SystemMarquette Medical Systems, Inc. · 1998
- 3 generations backK992637 Muse Cardiovascular Information SystemGeneral Electric Medical Systems Information Techn · 1999 · Recalled
- 2 generations backK023100 Accusketch Cardiac Quantitative System W/ Advanced Analysis ComponentsGeneral Electric Medical Systems Information Techn · 2002
- 1 generation backK042525 Centricity Radiology RA600/Centricity Cardiology CA1000/Centricity…Ge Medical Systems Information Technologies · 2004 · Recalled
- This deviceK063628 Centricity Radiology RA600, Cardiology CA1000 and Digital HardcopyGe Healthcare Integrated IT Solutions · 2006
- Descendant · cites it directly · 8 of its ownK081018 Syngo Dynamics Version 7.0Siemens Medical Solutions · 2008
- Descendant · 2 generations on · 7 of its ownK102150 Syngo Dynamics, Version 9.0Siemens Medical Solutions USA, Inc. · 2010 · Recalled
- Descendant · 3 generations on · 5 of its ownK123922 Syngo DynamicsSiemens Medical Solutions USA, Inc. · 2013
- Descendant · 4 generations on · 4 of its ownK171053 syngo Dynamics Version VA30Siemens Healthcare GmbH · 2017
- Descendant · cites it directly · 4 of its ownK081630 Mammo WorkstationImage Diagnost International GmbH · 2008
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K081018Syngo Dynamics Version 7.0Siemens Medical Solutions · 2008 · cites it directly8descendants
- K102150Syngo Dynamics, Version 9.0Siemens Medical Solutions USA, Inc. · 2010 · 2 generations on7descendants
- K123922Syngo DynamicsSiemens Medical Solutions USA, Inc. · 2013 · 3 generations on5descendants
- K171053syngo Dynamics Version VA30Siemens Healthcare GmbH · 2017 · 4 generations on4descendants
- K081630Mammo WorkstationImage Diagnost International GmbH · 2008 · cites it directly4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K842308 | 12SSL-SC | Marquette Electronics, Inc. | 1984 | — |
| −4 | K980495 | Muse Cardiovascular Information System | Marquette Medical Systems, Inc. | 1998 | — |
| −3 | K992637 | Muse Cardiovascular Information System | General Electric Medical Systems Information Techn | 1999 | 1 |
| −2 | K023100 | Accusketch Cardiac Quantitative System W/ Advanced Analysis Components | General Electric Medical Systems Information Techn | 2002 | — |
| −1 | K042525 | Centricity Radiology RA600/Centricity Cardiology CA1000/Centricity Digital… | Ge Medical Systems Information Technologies | 2004 | 3 |
| 0 (this device) | K063628 | Centricity Radiology RA600, Cardiology CA1000 and Digital Hardcopy | Ge Healthcare Integrated IT Solutions | 2006 | — |
| +1 | K081018 | Syngo Dynamics Version 7.0 | Siemens Medical Solutions | 2008 | — |
| +2 | K102150 | Syngo Dynamics, Version 9.0 | Siemens Medical Solutions USA, Inc. | 2010 | 7 |
| +3 | K123922 | Syngo Dynamics | Siemens Medical Solutions USA, Inc. | 2013 | — |
| +4 | K171053 | syngo Dynamics Version VA30 | Siemens Healthcare GmbH | 2017 | — |
| +1 | K081630 | Mammo Workstation | Image Diagnost International GmbH | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 2 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 2 | 0 |
| 2010 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 3 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LLZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LLZ device
- #1 K230955 syngo Application Softwarescore 21.5 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K042525 | Centricity Radiology RA600/Centricity Cardiology CA1000/Centricity Digital Hardcopy…Summary page 1…chiving and Communications Systems and Workstation Classification Names: 21 CFR 892.2050 System, Image Processing, Radiological Predicate Device: K042525: Centricity Radiology RA600 / Centricity Cardiology CA1000 / Centricity Digital Hardcopy Workstat… | 2004 |
| * | K023178 | Innova 4100Summary page 1…2525: Centricity Radiology RA600 / Centricity Cardiology CA1000 / Centricity Digital Hardcopy Workstation K023178 Innova 4100 (Specific features) K023100 Accusketch Cardiac Quantitative System W/ Advanced… | 2002 |
| * | K023100 | Accusketch Cardiac Quantitative System W/ Advanced Analysis ComponentsSummary page 1…Centricity Digital Hardcopy Workstation K023178 Innova 4100 (Specific features) K023100 Accusketch Cardiac Quantitative System W/ Advanced Analysis Components (Specific features)… | 2002 |
What descends from it? (18)
See all 183 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 19, 2025 | Class II | Z-1485-2025 | Software design | 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 service login credentials are able to be… |
| Feb 19, 2025 | Class II | Z-1486-2025 | Software design | 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 service login credentials are able to be… |
| Apr 28, 2022 | Class II | Z-1231-2022 | Software design | 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 measurement values when performed on… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 5 companies; a new generation was cleared every 2.2 years on median.
- 5 of the 16 ancestors have a recall of any class.
- Of its descendants, K081018 (Siemens Medical Solutions, 2008) has gone furthest, with 8 descendants of its own.
- 3 other devices also cite its predicate K042525.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LLZ
58in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLZ
173in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLZ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLZ
116in 2025
MAUDE reports naming product code LLZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 76 | 36 | 20 | 152 |
| 2008 | 94 | 52 | 32 | 154 |
| 2009 | 70 | 62 | 21 | 145 |
| 2010 | 51 | 98 | 17 | 145 |
| 2011 | 106 | 79 | 30 | 454 |
| 2012 | 82 | 87 | 12 | 266 |
| 2013 | 95 | 84 | 64 | 1,130 |
| 2014 | 78 | 89 | 6 | 15,631 |
| 2015 | 64 | 90 | 16 | 211 |
| 2016 | 82 | 90 | 12 | 290 |
| 2017 | 78 | 107 | 5 | 104 |
| 2018 | 104 | 105 | 7 | 72 |
| 2019 | 74 | 107 | 2 | 88 |
| 2020 | 81 | 115 | 6 | 82 |
| 2021 | 83 | 116 | 3 | 70 |
| 2022 | 65 | 137 | 4 | 28 |
| 2023 | 87 | 157 | 8 | 26 |
| 2024 | 62 | 131 | 6 | 42 |
| 2025 | 58 | 173 | 11 | 116 |
| 2026 | 45 | 110 | 14 | — |
What is it indicated for?
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…
Read the full statement (252 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063628 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063628: Centricity Radiology RA600, Cardiology CA1000 and Digital Hardcopy.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063628
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026