510(k) · Cleared
ClearedInterView XP; InterView FUSION
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mediso Medical Imaging Systems, Lttd. · LLZ System, Image Processing, Radiological
Cleared on Mar 29, 2023 as substantially equivalent to K201103 (GE Healthcare, 2020) after a 266-day review. Its family tree reaches back 11 generations to 2001.
- Decided
- Mar 29, 2023
- Review
- 266 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K010641 (2001). 24 ancestors in all, the oldest K914350 (1991). No later device cites it as a predicate yet.
- Root · 11 generations backK010641 GE CT-Pet SystemGe Medical Systems, Inc. · 2001
- 7 generations between
- 3 generations backK130884 Xeleris 3.1 Processing and Review WorkstationGe Medical Systems F.I. Haifa · 2013
- 2 generations backK153355 Xeleris 4.0 Processing and Review WorkstationGE Healthcare · 2016
- 1 generation backK201103 Xeleris V Processing and Review SystemsGE Healthcare · 2020
- This deviceK221984 InterView XP; InterView FUSIONMediso Medical Imaging Systems, Lttd. · 2023
Show all 11 generations
- Root · 11 generations backK010641 GE CT-Pet SystemGe Medical Systems, Inc. · 2001
- 10 generations backK023988 GE Discovery LS SystemGE Medical Systems · 2003 · Recalled
- 9 generations backK040172 Modification to GE Discovery LS SystemGE Medical Systems · 2004 · Recalled
- 8 generations backK041543 GE Discovery STGE Healthcare · 2004 · Recalled
- 7 generations backK042863 SceniumSiemens Molecular Imaging, Ltd. · 2004
- 6 generations backK061545 Scenium 1.1Siemens Molecular Imaging, Ltd. · 2006
- 5 generations backK121074 Scenium 2.0Siemens Medical Solutions USA, Inc. · 2012
- 4 generations backK123528 SceniumSiemens Medical Solutions USA, Inc. · 2012
- 3 generations backK130884 Xeleris 3.1 Processing and Review WorkstationGe Medical Systems F.I. Haifa · 2013
- 2 generations backK153355 Xeleris 4.0 Processing and Review WorkstationGE Healthcare · 2016
- 1 generation backK201103 Xeleris V Processing and Review SystemsGE Healthcare · 2020
- This deviceK221984 InterView XP; InterView FUSIONMediso Medical Imaging Systems, Lttd. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K010641 | GE CT-Pet System | Ge Medical Systems, Inc. | 2001 | — |
| −10 | K023988 | GE Discovery LS System | GE Medical Systems | 2003 | 1 |
| −9 | K040172 | Modification to GE Discovery LS System | GE Medical Systems | 2004 | 5 |
| −8 | K041543 | GE Discovery ST | GE Healthcare | 2004 | 1 |
| −7 | K042863 | Scenium | Siemens Molecular Imaging, Ltd. | 2004 | — |
| −6 | K061545 | Scenium 1.1 | Siemens Molecular Imaging, Ltd. | 2006 | — |
| −5 | K121074 | Scenium 2.0 | Siemens Medical Solutions USA, Inc. | 2012 | — |
| −4 | K123528 | Scenium | Siemens Medical Solutions USA, Inc. | 2012 | — |
| −3 | K130884 | Xeleris 3.1 Processing and Review Workstation | Ge Medical Systems F.I. Haifa | 2013 | — |
| −2 | K153355 | Xeleris 4.0 Processing and Review Workstation | GE Healthcare | 2016 | — |
| −1 | K201103 | Xeleris V Processing and Review Systems | GE Healthcare | 2020 | — |
| 0 (this device) | K221984 | InterView XP; InterView FUSION | Mediso Medical Imaging Systems, Lttd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 2 | 0 |
| 1997 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2010 | 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? (1)
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 |
|---|---|---|---|
| * | K201103 | Xeleris V Processing and Review SystemsSummary page 6…Marketed Device To Which The Device Is Substantially Equivalent The InterView XP is substantially equivalent to the Xeleris V Processing and Review Systems cleared under K201103. Description of the Device InterView XP is a DICOM image visualization and post-processing Software as Medical Device (SaMD). I… | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 7 companies; a new generation was cleared every 1.5 years on median.
- 7 of the 24 ancestors have a recall of any class.
- 2 other devices also cite its predicate K201103.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
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?
InterView XP is a Software as Medical Device (SaMD) aimed at reviewing medical images such as planar scans (Static, Whole Body, Dynamic, Multi-Gated) and tomographic scans (SPECT, Gated SPECT) acquired by gamma cameras. Review of other image modalities is also supported. Common Users for clinical purposes are trained medical professionals, including clinicians and technicians in hospitals or imaging centers. Software components provide functions for…
Read the full statement (206 words)
InterView XP is a Software as Medical Device (SaMD) aimed at reviewing medical images such as planar scans (Static, Whole Body, Dynamic, Multi-Gated) and tomographic scans (SPECT, Gated SPECT) acquired by gamma cameras. Review of other image modalities is also supported. Common Users for clinical purposes are trained medical professionals, including clinicians and technicians in hospitals or imaging centers. Software components provide functions for image display, manipulation, enhancements, analysis and quantification. This device is not indicated for mammography use or dental diagnostics. The software provides diagnostic information, however, diagnostic decision cannot be based solely on the software. InterView XP has no specific target population.
InterView FUSION is a Software as Medical Device (SaMD) aimed at reviewing medical im- ages such as planar scans and tomographic scans from SPECT, PET, CT, and MRI modalities. Review of other image modalities is also supported. The common users for clinical purposes are trained medical professionals, including clinicians and technicians in hospitals or imaging centers. Software components provide functions for image display, manipulation, enhancements, analysis, and quantification. This device is not indicated for mammography use or dental diagnostics. The software provides diagnostic information — however, diagnostic decisions cannot be based solely on this software. InterView FUSION has no specific target population.
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/K221984 · printed Nov 5, 2026
Cite this page
510(k) Report. “K221984: InterView XP; InterView FUSION.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K221984
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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