510(k) Report

510(k) · Cleared

Cleared

Oasis Release 1.0

K071584510(k) TraditionalCleared Aug 31, 200781-day reviewClass II21 CFR 892.2050

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Segami Corporation · LLZ System, Image Processing, Radiological

Cleared on Aug 31, 2007 after an 81-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 4 later devices descend from it.

Decided
Aug 31, 2007
Review
81 days
Class
Class II
Product code
LLZ
Recalls
None
Predicates
0

4 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2014: 1 descendant cleared2015: 1 descendant cleared2016: 1 descendant cleared2018: 1 descendant cleared20052010201520202025
  1. This deviceK071584 Oasis Release 1.0Segami Corporation · 2007
  2. Descendant · cites it directly · 3 of its ownK133654 SceniumSiemens Medical Solutions USA, Inc. · 2014
  3. Descendant · 2 generations on · 2 of its ownK150192 SceniumSiemens Medical Solutions USA, Inc. · 2015
  4. Descendant · 3 generations on · 1 of its ownK162339 SceniumSiemens Medical Solutions USA, Inc. · 2016
  5. Descendant · 4 generations on · 0 of its ownK173597 Scenium VE20 SoftwareSiemens Medical Solutions USA, Inc. · 2018

Most influential descendants

Showing 4 of 4 · See all
  • K133654SceniumSiemens Medical Solutions USA, Inc. · 2014 · cites it directly3descendants
  • K150192SceniumSiemens Medical Solutions USA, Inc. · 2015 · 2 generations on2descendants
  • K162339SceniumSiemens Medical Solutions USA, Inc. · 2016 · 3 generations on1descendant
  • K173597Scenium VE20 SoftwareSiemens Medical Solutions USA, Inc. · 2018 · 4 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K071584Oasis Release 1.0Segami Corporation2007—
+1K133654SceniumSiemens Medical Solutions USA, Inc.2014—
+2K150192SceniumSiemens Medical Solutions USA, Inc.2015—
+3K162339SceniumSiemens Medical Solutions USA, Inc.2016—
+4K173597Scenium VE20 SoftwareSiemens Medical Solutions USA, Inc.2018—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201410
201510
201610
201810
FIG. 1 — Lineage of K071584, 2007–2018Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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. #1 K230955 syngo Application Softwarescore 21.5 · 11 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (4)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K133654SceniumSiemens Medical Solutions USA, Inc.20143

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?

  • Of its descendants, K133654 (Siemens Medical Solutions USA, Inc., 2014) has gone furthest, with 3 descendants of its own.

How does its category compare?

All LLZ devices

LLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · LLZ

58in 2025

2007: 762008: 942009: 702010: 512011: 1062012: 822013: 952014: 782015: 642016: 822017: 782018: 1042019: 742020: 812021: 832022: 652023: 872024: 622025: 582026 (partial year): 45
2007high 106 (2011) · low 51 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LLZ

173in 2025

2007: 36 days median2008: 52 days median2009: 62 days median2010: 98 days median2011: 79 days median2012: 87 days median2013: 84 days median2014: 89 days median2015: 90 days median2016: 90 days median2017: 107 days median2018: 105 days median2019: 107 days median2020: 115 days median2021: 116 days median2022: 137 days median2023: 157 days median2024: 131 days median2025: 173 days median2026 (partial year): 110 days median
2007high 173 (2025) · low 36 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LLZ

11in 2025

2007: 202008: 322009: 212010: 172011: 302012: 122013: 642014: 62015: 162016: 122017: 52018: 72019: 22020: 62021: 32022: 42023: 82024: 62025: 112026 (partial year): 14
2007high 64 (2013) · low 2 (2019)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LLZ

116in 2025

2007: 1522008: 1542009: 1452010: 1452011: 4542012: 2662013: 1,1302014: 15,6312015: 2112016: 2902017: 1042018: 722019: 882020: 822021: 702022: 282023: 262024: 422025: 116
2007high 15,631 (2014) · low 26 (2023)2025

MAUDE reports naming product code LLZ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007763620152
2008945232154
2009706221145
2010519817145
20111067930454
2012828712266
20139584641,130
20147889615,631
2015649016211
2016829012290
2017781075104
2018104105772
201974107288
202081115682
202183116370
202265137428
202387157826
202462131642
20255817311116
20264511014—

What is it indicated for?

The Oasis system is indicated for the processing and review of scintigraphy data and other related diagnostic medical images produced by DICOM-based multimodality sources. These sources may include, but are not limited to, radiological diagnostic systems, picture archival computers (PACS), and processing workstations. Oasis is capable of processing and displaying the medical image data in traditional formats, as well as in pseudo three-dimensional…

Read the full statement (122 words)

The Oasis system is indicated for the processing and review of scintigraphy data and other related diagnostic medical images produced by DICOM-based multimodality sources. These sources may include, but are not limited to, radiological diagnostic systems, picture archival computers (PACS), and processing workstations. Oasis is capable of processing and displaying the medical image data in traditional formats, as well as in pseudo three-dimensional renderings, and in various forms of animated sequences, showing kinetic attributes of the imaged organs. The Oasis system displays the processed images using an integrated computer. Oasis provides manual and automatic report creation plus the ability to view these reports remotely. Oasis also provides patient scheduling tools. This device is not used in the primary diagnosis of Mammography images.

Indications for use as stated in the FDA 510(k) statement.

More from Segami Corporation

4 FDA decisions under this applicant name. See the company

  • K070397Dgscope, Release 1.0Segami Corporation · 2007
  • K070683Mirage Cedars OptionSegami Corporation · 2007
  • K043441Mirage, Release 5.5Segami Corporation · 2005

Recent decisions in LLZ

The LLZ category page

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  • K263048Syngo Carbon Space (VA4)Siemens Healthineers AG · 2026
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https://510kreport.com/device/K071584 · printed Nov 4, 2026

Cite this page

510(k) Report. “K071584: Oasis Release 1.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071584

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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