510(k) · Cleared
ClearedView 1 Imaging
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Karl Storz Endoscopy America, Inc. · LLZ System, Image Processing, Radiological
Cleared on Dec 13, 2011 as substantially equivalent to K063392 (Imco Technologies, 2006) after a 106-day review. Its family tree reaches back 6 generations to 1995.
- Decided
- Dec 13, 2011
- Review
- 106 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K945188 (1995). 15 ancestors in all, the oldest K920319 (1992). No later device cites it as a predicate yet.
- Root · 6 generations backK945188 Cemax Vipstation and/or SoftwareCemax, Inc. · 1995
- 5 generations backK961023 Aidp (Accuimage Image Display Processor)Accuimage, Inc. · 1996
- 4 generations backK994329 Iivs Integrated Image Viewing StationTerarecon,Inc. · 2000
- 3 generations backK012086 Aquariusnet ServerTerarecon,Inc. · 2001
- 2 generations backK051809 Easyviz, Easyviz System, Easyviz Pacs System, Easyviz Image and Data…Medical Insight A/S · 2005
- 1 generation backK063392 Imco-StatImco Technologies · 2006
- This deviceK112480 View 1 ImagingKarl Storz Endoscopy America, Inc. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K945188 | Cemax Vipstation and/or Software | Cemax, Inc. | 1995 | — |
| −5 | K961023 | Aidp (Accuimage Image Display Processor) | Accuimage, Inc. | 1996 | — |
| −4 | K994329 | Iivs Integrated Image Viewing Station | Terarecon,Inc. | 2000 | — |
| −3 | K012086 | Aquariusnet Server | Terarecon,Inc. | 2001 | — |
| −2 | K051809 | Easyviz, Easyviz System, Easyviz Pacs System, Easyviz Image and Data… | Medical Insight A/S | 2005 | — |
| −1 | K063392 | Imco-Stat | Imco Technologies | 2006 | — |
| 0 (this device) | K112480 | View 1 Imaging | Karl Storz Endoscopy America, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 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 |
|---|---|---|---|
| * | K063392 | Imco-StatSummary page 1…physicians to access these data and images via any standard web browser-based devices. Substantial Equivalence: VIEWi Imaging is substantially equivalent to IMCO- STAT (K063392). Both devices share the same indications for use and fundamental technologies, which is using DICOM 3.0 communication protocols… | 2006 |
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 16 years and passes through 6 companies; a new generation was cleared every 3.7 years on median.
- 1 of the 15 ancestors has a recall of any class.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
VIEWi Imaging consists of software that receives digital images and data from existing imaging equipments using DICOM 3.0 communication protocols. Images and data are stored on the server in deflate compressed image and proprietary header formats. The algorithms used to create compressed images follow known and accepted protocols, such as JPEG. VIEWi Imaging is designed to serve as an accessory to a Picture Archiving and Communication System (PACS). It…
Read the full statement (135 words)
VIEWi Imaging consists of software that receives digital images and data from existing imaging equipments using DICOM 3.0 communication protocols. Images and data are stored on the server in deflate compressed image and proprietary header formats. The algorithms used to create compressed images follow known and accepted protocols, such as JPEG.
VIEWi Imaging is designed to serve as an accessory to a Picture Archiving and Communication System (PACS). It is used with general purpose computing hardware for the display of medical image data and patient information. It is designed to provide storage, routing and display of DICOM image data through an executable application as well as in a web based format.
VIEWi Imaging is intended for use as review tool by trained professionals, such as physicians, and must not be reviewed for primary image interpretations.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112480 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112480: View 1 Imaging.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112480
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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