510(k) · Cleared
ClearedPerfscape V2.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olea Medical · LLZ System, Image Processing, Radiological
Cleared on Nov 4, 2011 as substantially equivalent to K090546 (Nordicimaginglab AS, 2009) after a 193-day review. Its family tree reaches back 8 generations to 1990. 53 later devices descend from it.
- Decided
- Nov 4, 2011
- Review
- 193 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K896095 (1990). 9 ancestors in all. 53 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 7 generations backK962699 Radworks Medical Imaging SoftwareApplicare Medical Imaging, B.V. · 1996
- 6 generations backK982862 Radworks Medical Imaging Software with Quality Control ModuleApplicare Medical Imaging, B.V. · 1998
- 5 generations backK012211 Efilm WorkstationEfilm Medical, Inc. · 2001 · Recalled
- 4 generations backK020995 Efilm Workstation with ModulesEfilm Medical, Inc. · 2002 · Recalled
- 3 generations backK063539 Nordic Image Control and Evaluation (Nice) Software, Version 2.1Nordicicemedical AS · 2007
- 2 generations backK082441 Nordicice SoftwareNordicimaginglab AS · 2008 · Recalled
- 1 generation backK090546 Modification to Nordicice SoftwareNordicimaginglab AS · 2009
- This deviceK111161 Perfscape V2.0Olea Medical · 2011
- Descendant · cites it directly · 51 of its ownK120196 Olea SphereOlea Medical · 2012
- Descendant · 2 generations on · 29 of its ownK121447 Ischema View RapidIschemaview, Inc. · 2013
- Descendant · 2 generations on · 20 of its ownK132095 Olea SphereOlea Medical · 2013
- Descendant · 3 generations on · 17 of its ownK172477 iSchemaView RAPIDIschemaview, Inc. · 2018
- Descendant · 3 generations on · 17 of its ownK152602 Olea Sphere V3.0Olea Medical · 2016
Showing 5 of 53 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 53 · See all- K120196Olea SphereOlea Medical · 2012 · cites it directly51descendants
- K121447Ischema View RapidIschemaview, Inc. · 2013 · 2 generations on29descendants
- K132095Olea SphereOlea Medical · 2013 · 2 generations on20descendants
- K172477iSchemaView RAPIDIschemaview, Inc. · 2018 · 3 generations on17descendants
- K152602Olea Sphere V3.0Olea Medical · 2016 · 3 generations on17descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K896095 | Images-on-Call Teleradiology System | Devices & Services Co. | 1990 | — |
| −7 | K962699 | Radworks Medical Imaging Software | Applicare Medical Imaging, B.V. | 1996 | — |
| −6 | K982862 | Radworks Medical Imaging Software with Quality Control Module | Applicare Medical Imaging, B.V. | 1998 | — |
| −5 | K012211 | Efilm Workstation | Efilm Medical, Inc. | 2001 | 1 |
| −4 | K020995 | Efilm Workstation with Modules | Efilm Medical, Inc. | 2002 | 2 |
| −3 | K063539 | Nordic Image Control and Evaluation (Nice) Software, Version 2.1 | Nordicicemedical AS | 2007 | — |
| −2 | K082441 | Nordicice Software | Nordicimaginglab AS | 2008 | 2 |
| −1 | K090546 | Modification to Nordicice Software | Nordicimaginglab AS | 2009 | — |
| 0 (this device) | K111161 | Perfscape V2.0 | Olea Medical | 2011 | — |
| +1 | K120196 | Olea Sphere | Olea Medical | 2012 | — |
| +2 | K121447 | Ischema View Rapid | Ischemaview, Inc. | 2013 | — |
| +2 | K132095 | Olea Sphere | Olea Medical | 2013 | — |
| +3 | K172477 | iSchemaView RAPID | Ischemaview, Inc. | 2018 | — |
| +3 | K152602 | Olea Sphere V3.0 | Olea Medical | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2016 | 2 | 0 |
| 2017 | 3 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 3 | 0 |
| 2022 | 3 | 0 |
| 2023 | 14 | 0 |
| 2024 | 5 | 0 |
| 2025 | 7 | 0 |
| 2026 | 4 | 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 |
|---|---|---|---|
| * | K090546 | Modification to Nordicice SoftwareSummary page 2…ing FDA cleared predicate device with regard to indications for use, performance and technological characteristics: 51 0(k) Number: K090546 Trade Name: Nordic Image Control and Evaluation (nICE) Software… | 2009 |
| † | K083491 | Neuroscape | 2009 |
What descends from it? (53)
See all 532 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 21 years and passes through 6 companies; a new generation was cleared every 2.4 years on median.
- 3 of the 9 ancestors have a recall of any class.
- Of its descendants, K120196 (Olea Medical, 2012) has gone furthest, with 51 descendants of its own.
- 8 other devices also cite its predicate K090546.
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?
PERESCAPE V2.O is a PACS system that allows the display, analysis and post-processing of dynamically acquired Magnetic Resonance (MRI) and Computed Tomography (CT) datasers to evaluate image intensity variations over time. PERESCAPE V2.O retrieves and accepts data from existing MRI and CT systems. Based on these data, PERESCAPE V2.O performs quality control checks, displays Diffusion Weighted Images (MRI only) and generates parametric maps such as…
Read the full statement (172 words)
PERESCAPE V2.O is a PACS system that allows the display, analysis and post-processing of dynamically acquired Magnetic Resonance (MRI) and Computed Tomography (CT) datasers to evaluate image intensity variations over time.
PERESCAPE V2.O retrieves and accepts data from existing MRI and CT systems. Based on these data, PERESCAPE V2.O performs quality control checks, displays Diffusion Weighted Images (MRI only) and generates parametric maps such as Relative Blood Volume, Relative Blood Flow, Relative Mean Transit Time, Time to Peak, Impulse Response Time to Peak, permeability and leakage between intravascular and extracellular space (MRI only), and temporal Maximum Intensity Projection (CT only). PERFSCAPE V2.O also generates Diffusion Weighted Images and/or Diffusion Tensor Images (MRI only).
These images, when interpreted by a trained physician, may yield clinically useful information.
PEREFSCAPE V2.0 is compliant with the DICOM standard allowing the system to visualize medical images. The system is a multiplatform software running on Windows, Mac and Linux operating systems.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111161 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111161: Perfscape V2.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111161
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