510(k) · Cleared
ClearedPlatinum Reading, Review & Analysis Workstation
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GE Medical Systems · LLZ System, Image Processing, Radiological
Cleared on Jun 18, 1998 after a 76-day review. The FDA summary names its predicate without a number. 1 of the 356 devices in its family, counting itself, has a Class I recall. 355 later devices descend from it.
- Decided
- Jun 18, 1998
- Review
- 76 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 0
355 later devices descend from it, 3 citing it directly. 1 of the 356 devices in this family, counting this one, has a Class I recall.
- This deviceK981217 Platinum Reading, Review & Analysis WorkstationGE Medical Systems · 1998
- Descendant · cites it directly · 354 of its ownK023557 Centricity Pacs PlusGE Medical Systems · 2002
- Descendant · 2 generations on · 324 of its ownK043415 Centricity Pacs SystemGe Medical Systems Information Technologies · 2005 · Recalled
- Descendant · 3 generations on · 287 of its ownK071964 Mim 4.1 (Seastar)Mimvista Corp. · 2007 · Recalled
- Descendant · 4 generations on · 200 of its ownK091373 Syngo TruedSiemens Medical Solutions USA, Inc. · 2009
- Descendant · 4 generations on · 79 of its ownK103576 Mim 5.2 (Brachy)Mim Software, Inc. · 2011
Showing 5 of 355 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K250443 MAGNETOM Avanto Fit; MAGNETOM Skyra Fit…9 generations on · 2025
Most influential descendants
Showing 5 of 355 · See all- K023557Centricity Pacs PlusGE Medical Systems · 2002 · cites it directly354descendants
- K043415Centricity Pacs SystemGe Medical Systems Information Technologies · 2005 · 2 generations on324descendants
- K071964Mim 4.1 (Seastar)Mimvista Corp. · 2007 · 3 generations on287descendants
- K091373Syngo TruedSiemens Medical Solutions USA, Inc. · 2009 · 4 generations on200descendants
- K103576Mim 5.2 (Brachy)Mim Software, Inc. · 2011 · 4 generations on79descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K981217 | Platinum Reading, Review & Analysis Workstation | GE Medical Systems | 1998 | — |
| +1 | K023557 | Centricity Pacs Plus | GE Medical Systems | 2002 | — |
| +2 | K043415 | Centricity Pacs System | Ge Medical Systems Information Technologies | 2005 | 23 |
| +3 | K071964 | Mim 4.1 (Seastar) | Mimvista Corp. | 2007 | 2 |
| +4 | K091373 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2009 | — |
| +4 | K103576 | Mim 5.2 (Brachy) | Mim Software, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 8 | 0 |
| 2006 | 5 | 0 |
| 2007 | 4 | 0 |
| 2008 | 5 | 0 |
| 2009 | 2 | 0 |
| 2010 | 5 | 0 |
| 2011 | 12 | 0 |
| 2012 | 7 | 0 |
| 2013 | 7 | 0 |
| 2014 | 9 | 0 |
| 2015 | 9 | 0 |
| 2016 | 13 | 0 |
| 2017 | 14 | 0 |
| 2018 | 27 | 0 |
| 2019 | 23 | 0 |
| 2020 | 25 | 0 |
| 2021 | 23 | 0 |
| 2022 | 28 | 0 |
| 2023 | 26 | 0 |
| 2024 | 28 | 0 |
| 2025 | 36 | 1 |
| 2026 | 36 | 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.
1 device in this family has a Class I recall. 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? (7)
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 |
|---|---|---|---|
| * | — | GE Medical Systems PACS Image Display Workstations Named without a submission number | |
| * | — | GE Medical Systems PACS Image Acquisition Workstations Named without a submission number | |
| * | — | GE Medical Systems PACS Network Storage Products Named without a submission number | |
| * | — | GE Medical Systems PACS LiteBox Named without a submission number | |
| * | — | GE Medical Systems Advantage Windows Review Workstation Named without a submission number | |
| * | — | ISG Technologies’ ISG Viewing and Reading Stations (VRS) Named without a submission number | |
| * | — | ISG Technologies’ ISG Silhouette Radiology Application products Named without a submission number |
What descends from it? (355)
See all 3553 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileSiemens Healthcare GmbH · 2025 · 9 generations on · ◆ in the 2025 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- Of its descendants, K023557 (GE Medical Systems, 2002) has gone furthest, with 354 descendants of its own.
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?
The PLATINUM Image Reading, Review & Analysis Workstation is an image display
workstation that is intended for use by qualified physicians for reading, reviewing and analyzing
computerized digital images and reports acquired from imaging devices such as CT, MRI or
computed radiography systems. PLATINUM is used to view digital images which are obtained
either from a GE PACS System or a DICOM device, i.e. Acquisition, Archive or Workstation.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K981217 · printed Nov 6, 2026
Cite this page
510(k) Report. “K981217: Platinum Reading, Review & Analysis Workstation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K981217
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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