510(k) · Cleared
ClearedIpacs Prism
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Realtimeimage, Inc. · LLZ System, Image Processing, Radiological
Cleared on May 29, 2003 as substantially equivalent to K013630 (Stentor, Inc., 2001) after an 80-day review. Its family tree reaches back 2 generations to 1994. 3 later devices descend from it.
- Decided
- May 29, 2003
- Review
- 80 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K942120 (1994). 3 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK942120 Advantage Windows Diagnostic X-Ray WorkstationGE Medical Systems · 1994
- 1 generation backK013630 Isite RadiologyStentor, Inc. · 2001
- This deviceK030751 Ipacs PrismRealtimeimage, Inc. · 2003
- Descendant · cites it directly · 1 of its ownK080290 XviewnetAmerican Radiologist Network, Inc. · 2008
- Descendant · 2 generations on · 0 of its ownK081792 Spy Analysis Toolkit, Model SA9000Novadaq Technologies, Inc. · 2008
- Descendant · cites it directly · 0 of its ownK050298 Ipacs Prism-5.0Realtimeimage, Inc. · 2005
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K942120 | Advantage Windows Diagnostic X-Ray Workstation | GE Medical Systems | 1994 | — |
| −1 | K013630 | Isite Radiology | Stentor, Inc. | 2001 | — |
| 0 (this device) | K030751 | Ipacs Prism | Realtimeimage, Inc. | 2003 | — |
| +1 | K080290 | Xviewnet | American Radiologist Network, Inc. | 2008 | — |
| +2 | K081792 | Spy Analysis Toolkit, Model SA9000 | Novadaq Technologies, Inc. | 2008 | — |
| +1 | K050298 | Ipacs Prism-5.0 | Realtimeimage, Inc. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2008 | 2 | 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 |
|---|---|---|---|
| * | K013630 | Isite Radiology | 2001 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 9 years and passes through 3 companies; a new generation was cleared every 7.4 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K080290 (American Radiologist Network, Inc., 2008) has gone furthest, with 1 descendant of its own.
- 6 other devices also cite its predicate K013630.
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?
iPACS PrismTM from Real Time Image Inc. is a device that receives medical images and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations.
Typical users of this system are trained professionals, including but not limited to physicians, nurses, and technicians.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030751 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030751: Ipacs Prism.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030751
Report an extraction error
Are you the manufacturer?
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