510(k) · Cleared
ClearedZiostation2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ziosoft, Inc. · LLZ System, Image Processing, Radiological
Cleared on May 5, 2020 as substantially equivalent to K181892 (Ziosoft, Inc., 2018) and 3 other predicates after an 88-day review. Its family tree reaches back 15 generations to 1993. 10 of the 295 devices in its family, counting itself, have a Class I recall.
- Decided
- May 5, 2020
- Review
- 88 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 15 generations to K926514 (1993). 294 ancestors in all, the oldest K837107 (1983). No later device cites it as a predicate yet. 10 of the 295 devices in this family, counting this one, have a Class I recall.
- Root · 15 generations backK926514 Endoscopic Ultrasound System Type 20Olympus Corp. · 1993 · Recalled
- 11 generations between
- 3 generations backK110093 Superdimension Marker Delivery KitSuperdimension, Inc. · 2011
- 2 generations backK112051 Lungpoint Planning and Virtual Bronchoscopic Navigation (VBN) SoftwareBroncus Technologies, Inc. · 2011
- 1 generation backK181892 Ziostation2Ziosoft, Inc. · 2018
- This deviceK200315 Ziostation2Ziosoft, Inc. · 2020
Show all 15 generations
- Root · 15 generations backK926514 Endoscopic Ultrasound System Type 20Olympus Corp. · 1993 · Recalled
- 14 generations backK951994 Olympus EU-M30 Endoscopic Ultrasound CenterOlympus America, Inc. · 1996
- 13 generations backK982323 Olympus UM 2R/3R Ultrasonic Probes and Associated Ancillary…Olympus America, Inc. · 1998
- 12 generations backK042438 Superdimension/BronchusSuperdimension, Ltd. · 2004 · Recalled
- 11 generations backK052260 Superdimension/Bronchus 4.1Superdimension, Ltd. · 2005 · Recalled
- 10 generations backK052852 Superdimension/Bronchus PremiumSuperdimension, Ltd. · 2005 · Recalled
- 9 generations backK062315 Superdimension/Bronchus Premium 2Superdimension, Ltd. · 2006 · Recalled
- 8 generations backK071473 Modification to Superdimension/Bronchus Premium 2Superdimension, Ltd. · 2007
- 7 generations backK080271 Inreach SystemSuperdimension, Ltd. · 2008
- 6 generations backK081379 Modification to Inreach SystemSuperdimension, Ltd. · 2008
- 5 generations backK092365 Inreach System, Model AAS00161-02Superdimension, Ltd. · 2009
- 4 generations backK102604 I-Logic Inreach SystemSuperdimension, Ltd. · 2010
- 3 generations backK110093 Superdimension Marker Delivery KitSuperdimension, Inc. · 2011
- 2 generations backK112051 Lungpoint Planning and Virtual Bronchoscopic Navigation (VBN) SoftwareBroncus Technologies, Inc. · 2011
- 1 generation backK181892 Ziostation2Ziosoft, Inc. · 2018
- This deviceK200315 Ziostation2Ziosoft, Inc. · 2020
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K926514 | Endoscopic Ultrasound System Type 20 | Olympus Corp. | 1993 | 1 |
| −14 | K951994 | Olympus EU-M30 Endoscopic Ultrasound Center | Olympus America, Inc. | 1996 | — |
| −13 | K982323 | Olympus UM 2R/3R Ultrasonic Probes and Associated Ancillary Equipment, for… | Olympus America, Inc. | 1998 | — |
| −12 | K042438 | Superdimension/Bronchus | Superdimension, Ltd. | 2004 | 1 |
| −11 | K052260 | Superdimension/Bronchus 4.1 | Superdimension, Ltd. | 2005 | 2 |
| −10 | K052852 | Superdimension/Bronchus Premium | Superdimension, Ltd. | 2005 | 1 |
| −9 | K062315 | Superdimension/Bronchus Premium 2 | Superdimension, Ltd. | 2006 | 1 |
| −8 | K071473 | Modification to Superdimension/Bronchus Premium 2 | Superdimension, Ltd. | 2007 | — |
| −7 | K080271 | Inreach System | Superdimension, Ltd. | 2008 | — |
| −6 | K081379 | Modification to Inreach System | Superdimension, Ltd. | 2008 | — |
| −5 | K092365 | Inreach System, Model AAS00161-02 | Superdimension, Ltd. | 2009 | — |
| −4 | K102604 | I-Logic Inreach System | Superdimension, Ltd. | 2010 | — |
| −3 | K110093 | Superdimension Marker Delivery Kit | Superdimension, Inc. | 2011 | — |
| −2 | K112051 | Lungpoint Planning and Virtual Bronchoscopic Navigation (VBN) Software | Broncus Technologies, Inc. | 2011 | — |
| −1 | K181892 | Ziostation2 | Ziosoft, Inc. | 2018 | — |
| 0 (this device) | K200315 | Ziostation2 | Ziosoft, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1987 | 1 | 0 |
| 1988 | 3 | 0 |
| 1989 | 2 | 0 |
| 1990 | 1 | 0 |
| 1991 | 8 | 0 |
| 1992 | 2 | 0 |
| 1993 | 4 | 0 |
| 1994 | 4 | 0 |
| 1995 | 7 | 0 |
| 1996 | 13 | 0 |
| 1997 | 8 | 0 |
| 1998 | 13 | 0 |
| 1999 | 9 | 0 |
| 2000 | 16 | 0 |
| 2001 | 22 | 1 |
| 2002 | 18 | 1 |
| 2003 | 16 | 2 |
| 2004 | 24 | 2 |
| 2005 | 20 | 2 |
| 2006 | 15 | 0 |
| 2007 | 14 | 2 |
| 2008 | 17 | 0 |
| 2009 | 10 | 0 |
| 2010 | 1 | 0 |
| 2011 | 10 | 0 |
| 2012 | 8 | 0 |
| 2013 | 5 | 0 |
| 2014 | 4 | 0 |
| 2015 | 3 | 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.
10 devices in this family have 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 21.6 · 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? (4)
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 |
|---|---|---|---|
| * | K181892 | Ziostation2Summary page 5…are Tool Device Name 510(k) Number Ziostation2 K181892 syngo.CT Dual Energy K150757 SOMATOM Force… | 2018 |
| * | K150757 | syngo.CT Dual EnergySummary page 5…510(k) Number Ziostation2 K181892 syngo.CT Dual Energy K150757 SOMATOM Force K133589 SOMATOM Definition… | 2015 |
| * | K133589 | Somatom ForceSummary page 5…K181892 syngo.CT Dual Energy K150757 SOMATOM Force K133589 SOMATOM Definition Flash K121072 The already-cleared Ziostation2 (K… | 2014 |
| * | K121072 | Somatom Definition FlashSummary page 5…K150757 SOMATOM Force K133589 SOMATOM Definition Flash K121072 The already-cleared Ziostation2 (K181892) is the primary predicate device. Device Description Ziostation2 is a basi… | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (10 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.
- K063559Achieva, Intera and Panorama 1.0T, Release 2.5Philips Medical Systems · 2007 · 2 generations back · ◆ in the 2007 ancestors bar of FIG. 11 Class I recall
- K072237Magnetom VerioSiemens Medical Solutions USA, Inc. · 2007 · 3 generations back · ◆ in the 2007 ancestors bar of FIG. 11 Class I recall
- K052078Achieva, Intera and Panorama 1.0 Release 2-SeriesPhilips Medical Systems Nederland B.V. · 2005 · 3 generations back · ◆ in the 2005 ancestors bar of FIG. 11 Class I recall
- K043147Achieva FamilyPhilips Medical Systems North America Co. · 2005 · 3 generations back · ◆ in the 2005 ancestors bar of FIG. 13 Class I recalls
- K041602Panorama 1.0TPhilips Medical Systems North America, Inc. · 2004 · 3 generations back · ◆ in the 2004 ancestors bar of FIG. 11 Class I recall
- K041476GE Signa Excite 1.5T MR System, GE Signa Excite 3.0T MR SystemGe Medical Systems, LLC · 2004 · 5 generations back · ◆ in the 2004 ancestors bar of FIG. 11 Class I recall
- K030874GE 3.0T Signa Infinity Twinspeed with Excite MR SystemGeneral Electric Co. · 2003 · 6 generations back · ◆ in the 2003 ancestors bar of FIG. 11 Class I recall
- K023984Modification to Olympus Bronchoscopes BF-40 Series, BF-240 Series, and BF-160 SeriesThe Olympus Optical Co. · 2003 · 6 generations back · ◆ in the 2003 ancestors bar of FIG. 114 Class I recalls
- K013636Signa Infinity MR System with Excite TechnologyGE Medical Systems · 2002 · 6 generations back · ◆ in the 2002 ancestors bar of FIG. 11 Class I recall
- K0122001.5T Infinity Twinspeed MR SystemGE Medical Systems · 2001 · 7 generations back · ◆ in the 2001 ancestors bar of FIG. 11 Class I recall
Nearest 5 of 10; all are on the web page.
What does this lineage say?
- The line of descent spans 27 years and passes through 6 companies; a new generation was cleared every 10 months on median.
- 94 of the 294 ancestors have a recall of any class; 10 have a Class I recall.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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?
• This application software is image processing application software available for installation onto customer-owned hardware. This application software can be networked to provide for sharing of resources. • This application software receives medical image data (CT, MRI, Ultrasound, Digital X-ray, X-ray Angiography, PET, SPECT, Nuclear Medicine, Secondary Capture, Mammography, X-ray Radiofluoroscopic image, and RT Image) from modalities or image archives…
Read the full statement (103 words)
• This application software is image processing application software available for installation onto customer-owned hardware. This application software can be networked to provide for sharing of resources.
• This application software receives medical image data (CT, MRI, Ultrasound, Digital X-ray, X-ray Angiography, PET, SPECT, Nuclear Medicine, Secondary Capture, Mammography, X-ray Radiofluoroscopic image, and RT Image) from modalities or image archives such as PACS through network or media, and provides for the viewing, quantification, manipulation, communication, printing and management of medical images.
• This application software is intended only for use by trained medical professionals to supplement generally accepted methods of interpreting radiological images.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200315 · printed Nov 3, 2026
Cite this page
510(k) Report. “K200315: Ziostation2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K200315
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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