K111161 · Olea Medical · LLZ · Nov 4, 2011 · Radiology
Device Facts
Record ID
K111161
Device Name
PERFSCAPE V2.0
Applicant
Olea Medical
Product Code
LLZ · Radiology
Decision Date
Nov 4, 2011
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 892.2050
Device Class
Class 2
Attributes
Software as a Medical Device
Indications for Use
PERFSCAPE V2.0 is a PACS system that allows the display, analysis and post-processing of dynamically acquired Magnetic Resonance (MRI) and Computed Tomography (CT) datasets to evaluate image intensity variations over time. PERFSCAPE V2.0 retrieves and accepts data from existing MRI and CT systems. Based on these data, PERFSCAPE V2.0 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 V2.0 also generates Diffusion Weighted Images and/or Diffusion Tensor Images (MRI only). These images, when interpreted by a trained physician, may vield clinically useful information. PERFSCAPE 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.
Device Story
PERFSCAPE V2.0 is a software-based PACS application for analyzing dynamic MRI and CT datasets. It ingests DICOM-compliant image data from existing scanners. The software performs quality control, motion correction, and organ mask generation. It utilizes established algorithms to compute parametric maps (e.g., Relative Blood Volume, Blood Flow, Mean Transit Time, Time to Peak, permeability/leakage, temporal MIP) and generates Diffusion Weighted/Tensor Images (DWI/DTI). Features include automated or interactive Arterial Input Function (AIF) and Venous Output Function (VOF) selection. Used in clinical settings by physicians, the software displays results in real-time, allowing export to PACS or local files. It integrates with NEUROSCAPE (K083491) for further study. By providing quantitative perfusion and diffusion maps, the device assists physicians in interpreting image intensity variations, potentially aiding clinical decision-making and patient diagnosis.
Clinical Evidence
No clinical data provided. Bench testing only.
Technological Characteristics
PACS software for Windows, Mac, and Linux. DICOM compliant. Features: automated/interactive AIF/VOF selection, motion correction, organ mask generation, and parametric map computation (perfusion/diffusion). Software-based; no hardware components. Connectivity via standard DICOM networking.
Indications for Use
Indicated for use by trained physicians to display, analyze, and post-process dynamically acquired MRI and CT datasets to evaluate image intensity variations over time. Not for primary interpretation of lossy compressed mammographic or digitized film screen images.
Regulatory Classification
Identification
A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.
Special Controls
*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
Predicate Devices
Nordic Image Control and Evaluation (nICE) Software (K090546)
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K111161
NOV - 4 2011 P 1/5
# 510(k) Summary
(in accordance with 21 CFR 807.92)
510(k) Number K
#### I. Applicant Information
| Applicant: | |
|------------|--|
|------------|--|
OLEA MEDICAL
| 93 avenue des Sorbiers, Zone Athelia IV |
|-----------------------------------------|
| La Ciotat 13600 |
| France |
Contact Person: Caroline Lene . Quality Manager Tel: (011) 33 4 42 71 24 20 Fax: (011) 33 4 42 71 24 27 e-mail: caroline.lene@olea-medical.com
Application Correspondent:
EMERGO GROUP INC. 611 West 5th Street, Third Floor Austin, TX 78701 U.S.A.
Contact Person: Kristi Gusman Project Manager Tel: (512) 327-9997 Fax: (512) 327-9998 e-mail: kristi@emergogroup.com
Date Prepared: April 15, 2011
#### II. Device Name and Classification
| Proprietary Name: | PERFSCAPE V2.0 |
|-----------------------|-----------------------------------------|
| Common/Usual Name: | PACS |
| Classification Name: | Picture Archiving Communications System |
| Regulation Number: | 892.2050 |
| Product Codes: | LLZ |
| Classification: | Class II |
| Classification Panel: | Radiology Devices |
510(k) - PERFSCAPE V2.0
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Image /page/1/Picture/0 description: The image shows the logo for Olea Medical. The logo consists of a cube with a human figure on one side and a pattern of dots on the other. To the right of the cube is the text "Olea" in a bold, sans-serif font, with the word "medical" in a smaller font below it.
K111161
P²/₄
#### III. Predicate Device
The PERFSCAPE V2.0 device is substantially equivalent to the following FDA cleared predicate device with regard to indications for use, performance and technological characteristics:
| 510(k) Number: | K090546 |
|----------------------|--------------------------------------------------------|
| Trade Name: | Nordic Image Control and Evaluation (nICE)<br>Software |
| Manufacturer: | NordicIceMedical AS |
| Classification Name: | Picture Archiving Communications System |
| Common/Usual Name: | PACS |
| Regulation Number: | 892.2050 |
| Product Codes: | LLZ |
| Classification: | Class II |
#### IV. Device Description
PERFSCAPE V2.0 is a software application designed to analyze dynamically acquired datasets. The software provides a wide range of basic image processing and manipulation functions applied to MRI or CT datasets.
Using well-established algorithms, parametric maps can be generated 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), temporal Maximum Intensity Projection (CT only). PERFSCAPE V2.0 also generates Diffusion Weighted Images and/or Diffusion Tensor Images (DWI and DTI, MRI only).
The PERFSCAPE V2.0 device includes critical features such as:
- Enables the computation of DWI and DTI maps from co-registered . Bxxx images (eg B0 B500 B1000);
- . Enables rapid creation of a complete array of critical parameter maps;
- Automated organ mask generation; .
- . View dynamic signal time course on a per-voxel basis;
- Integrated motion correction ; .
- Automatic and Interactive Arterial Input Function (AIF) selection; ●
- Automatic and Interactive Venous Output Function (VOF) selection; .
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Image /page/2/Picture/1 description: The image shows the logo for Olea Medical. The logo consists of a cube with a human figure on one side and a pattern of circles on another side. To the right of the cube is the text "Olea" in a larger font, with the word "MEDICAL" underneath in a smaller font.
- Export computed perfusion map to PACS or to DICOM files in . filesystem.
PERFSCAPE V2.0 also allows the user to view the computed maps using the NEUROSCAPE software (K083491).
Based on these common functionalities, Perfscape is divided into three modules named:
- MRI module, ●
- . CT module, and
- MRI-LC module. .
Each module is designed to address useful subsets of images.
#### V. Intended Use
PERFSCAPE V2.0 is a PACS system that allows the display, analysis and post-processing of dynamically acquired Magnetic Resonance (MRI) and Computed Tomography (CT) datasets to evaluate image intensity variations over time.
PERFSCAPE V2.0 retrieves and accepts data from existing MRI and CT systems. Based on these data, PERFSCAPE V2.0 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 V2.0 also generates Diffusion Weighted Images and/or Diffusion Tensor Images (MRI only).
These images, when interpreted by a trained physician, may vield clinically useful information.
PERFSCAPE 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.
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Image /page/3/Picture/1 description: The image shows the logo for Olea Medical. The logo consists of a cube with a human figure on one side and a pattern of dots on the other. To the right of the cube is the text "olea" in a bold, sans-serif font, with the word "MEDICAL" in a smaller font below it.
#### VI. Summary of the Technical Characteristics
PERFSCAPE V2.0 is a PACS software designed to access series of CT or MRI images in DICOM format. PERFSCAPE V2.0 analyzes dynamically acquired CT or MR datasets and generates parametric maps.
Used in combination with MRI datasets, PERFSCAPE V2.0 allows automatic or interactive and multiple selections of arterial input functions and displays map results of the selected slice in real time. The selected AIF can be manually filtered. It also allows generating, manually or automatically, an organ mask to remove non-organ voxels. PERFSCAPE V2.0 also allows computing DWI and DTI maps from Bxxx coregistered images.
Used in combination with CT datasets, PERFSCAPE V2.0 allows automatic or interactive and multiple selections of arterial input functions, venous output functions and displays map results of the selected slice in real time. The selected AIF can be manually filtered. It also allows generating, manually or automatically, an organ mask to remove non-organ voxels.
PERFSCAPE V2.0 allows creating a NEUROSCAPE (K083491) study with computed and/or imported maps. It also allows exporting the results as a DICOM study to the PACS or the file system.
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Image /page/4/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The logo includes the department's name in bold, uppercase letters. To the left of the text is a symbol that includes an eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Olea Medical % Ms. Kristi Gusman Project Manager Emergo Group, Inc. 611 West 5th Street, Third Floor AUSTIN TX 78701
NOV - 4 2011
Re: K11161
Trade/Device Name: PERFSCAPE V2.0 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: October 6, 2011 Received: October 7, 2011
Dear Ms. Gusman:
We have reviewed vour Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of
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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 5.10(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours.
Mary Pastel
Mary S. Pastel. Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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## 4. Indication for Use Statement
510(k) Number (if known): __|<\1\1 \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \
Device Name:
PERFSCAPE V2.0
### Indications for Use:
PERFSCAPE V2.0 is a PACS system that allows the display, analysis and postprocessing of dynamically acquired Magnetic Resonance (MRI) and Computed Tomography (CT) datasets to evaluate image intensity variations over time.
PERFSCAPE V2.0 retrieves and accepts data from existing MRI and CT systems. Based on these data, PERFSCAPE V2.0 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 V2.0 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.
PERFSCAPE 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.
Prescription Use X (Part 21 CFR 801 Subpart D)
510K
AND/OR '
Over-The-Counter Use (21 CFR 801 Subpart C)
Diagnostic
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH. Office of Device Evaluation (QDE).
Mury S. Patal
(Division Sign Off)
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
Page 1 of 1
Devices
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
