INVIA's Corridor4DM v2010 application is intended to provide processing quantification, and multidimensional review of the biodistribution of radionuclides in the body using planar and tomographic images. The application performs quantitative measurements of tracer uptake over time to aid in the interpretation of myocardial perfusion tomographic images. Cardiac CT interpretation and calcium quantification are optional features that are integrated into Corridor4DM (SPECT-CT and PET-CT). The calcium scoring package is a non-invasive diagnostic tool that can be used to evaluate the calcified plaques in the coronary arteries, a risk factor for coronary artery disease. Co-registration or fusion of volumetric data (ECT and/or CT) is provided as a quality control for the identification of structures where correlative spatial information is necessary for a diagnostic interpretation.
Device Story
Corridor4DM v2010 is a software application for processing, reviewing, and quantifying nuclear medicine, PET, and CT patient studies. Inputs include static, dynamic, gated planar, and gated/ungated ECT images. The device algorithmically determines and displays left ventricular endocardial and epicardial surfaces to provide quantitative assessments of cardiac function and perfusion. It supports co-registration/fusion of ECT and CT volumetric data. Used in clinical settings by trained medical professionals; the clinician retains ultimate responsibility for diagnostic assessment. Output includes 3D surface-rendered images, quantitative measurements, and exported diagnostic findings in DICOM, JPEG, TIFF, or AVI formats. Benefits include standardized quantitative assessment of myocardial perfusion and coronary artery calcification to assist in coronary artery disease diagnosis.
Clinical Evidence
Bench testing only. Validation testing was performed to confirm system performance and safety in accordance with the Risk Management Plan (ISO 14971) and FDA guidance for software and imaging devices. No clinical study data was required for this 510(k) submission.
Technological Characteristics
Software-based image processing application. Features include tomographic reconstruction, planar image processing, tracer uptake quantification, and cardiac function/perfusion analysis. Supports DICOM multi-frame and secondary screen capture. Operates on standard clinical workstations. Software validation conducted per ISO 14971.
Indications for Use
Indicated for patients undergoing nuclear medicine, PET, or CT imaging for evaluation of myocardial perfusion and coronary artery calcification. Intended for use by trained medical professionals to aid in diagnostic interpretation of cardiac function and disease.
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).
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#### 510(k) Summary
A) Submitted by: INVIA, LCC
3025 Boardwalk, Suite 200 Ann Arbor, MI 48108 Registration Number: 3004993756 Operator Number: 9069896
AUG 0 4 2010
1401279
Contact:
- MEDIcept 200 Homer Ave Ashland, MA 01721 F. David Rothkopf 508-231-8842 508-231-8861 Fax
B) Device Name: Corridor4DM v2010
Classification Name: System, Imaging Processing, Radiogical
Device Class:
21 CFR 892.1200 (KPS) 21 CFR 892.1750 (JAK 21 CFR 892.2050 (LLZ)
CLASS II
Product Code
KPS, JAK, LLZ
C) Substantially Equivalent (predicate) device(s):
Device Corridor4DM syngoCirculation DynamicPET Syngo® Circulation E.CAM Odyssey LX Model
Manufacturer INVIA, LLC Siemens Siemens Siemens Philips Medical
510(k) Number K080575 K083327 K063762 K023190 K003437 ·
D) Device Description:
Corridor4DM v2010 is a comprehensive application designed to process, review, and quantitatively analyze nuclear medicine, PET, and CT patient studies. The application provides tools to process, quantify, and display static, dynamic, gated planar,- standard ungated ECT images, ECG gated ECT images, and dynamic ECT images. ECT data is displayed on both a slice-by-slice basis and as 3-dimensional surface- rendered images in
Invia 510(k)
April 26, 2010
Corridor4DM v2010
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many user selectable formats. All of the image formats can be viewed as a single dataset or as a comparison of related datasets. Among several optional display screens are sideby-side displays optimized for the review of uncorrected and attenuation corrected cardiac images. .
Corridor4DM v2010 algorithmically determines and displays the left ventricular endocardial and epicardial surfaces. These surfaces provide quantitative assessments of cardiac functions. Corridor-4DM v2010 includes the ability to save and export diagnostic findings in a variety of formats. The application generates DICOM multi-frame (MFSC) and secondary screen captures (SSC) in addition to producing static (JPEG, TIFF) and dynamic (AVI) image files.
Corridor4DM v2010 is intended to be used only by trained medical professionals. The Clinician retains the ultimate responsibility for making the pertinent assessment based on their standard practices and visual assessment.
F) Intended Use:
INVIA's Corridor4DM application is intended to provide processing, quantification, and multidimensional review of the biodistribution of radionuclides in the body using planar and tomographic images. The application performs quantitative measurements of tracer uptake over time to aid in the interpretation of myocardial perfusion emission tomographic images. Cardiac CT interpretation and calcium quantification are optional features that are integrated into Corridor4DM (SPECT-CT and PET-CT).- The calcium scoring package is a non-invasive diagnostic tool that can be used to evaluate the calcified plaques in the coronary arteries, a risk factor for coronary artery disease. Coregistration or fusion of volumetric data (ECT and/or CT) is provided as a quality control for the identification of structures where correlative spatial information is necessary for a diagnostic interpretation.
G) Comparison to Predicate Device(s):
The Corridor4DM v2010 has the same technology, intended use, target population, and clinical setting as the predicate devices.
April 26, 2010
Corridor4DM v.2010
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The chart below compares the Corridor4DM v2010 device to predicate devices.
| Features | Corridor4DM<br>v2010 | Corridor4DM<br>K080575 | Syngo Circulation<br>Dynamic<br>K083327 | Syngo Circulation<br>K063762 | E. CAM<br>K023190 | Odyssey<br>K003437 |
|------------------------------------------------|----------------------|------------------------|-----------------------------------------|------------------------------|-------------------|--------------------|
| Product Code | KPS,<br>JAK,<br>LLZ | KPS,<br>JAK,<br>LLZ | LLZ | JAK | LLZ | LLZ |
| Reconstruction of<br>tomographic datasets | Yes | No | No | No | Yes | Yes |
| Processing of Planar<br>Images | Yes | No | No | No | Yes | Yes |
| Quantification of tracer<br>uptake over time | Yes | No | Yes<br>(PET only) | No | Yes<br>(NM only) | Yes<br>(NM only) |
| Digital image retrieval<br>of radiographs | Yes | Yes | Yes | Yes | Yes | Yes |
| Quantitative Estimates<br>of Cardiac Function | Yes | Yes | No | Yes | No | No |
| Quantitative estimates<br>of cardiac perfusion | Yes | Yes | Yes | Yes | No | No |
i
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Corridor4DM v.2010
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# H) Safety and Effectiveness:
The Corridor4DM v2010 application and safety is assessed via the Risk Management Plan in accordance with ISO 14971.
I) Guidance Documents:
Guidance for the Submission of Premarket Notifications for Emission Computed Tomography Devices and Accessories (SPECT and PET) and Nuclear Tomography Systems; Final, FDA December 3, 1998
Guidance for the Submission of Premarket Notifications for Medical Image Management Devices Document issued on: July 27, 2000
Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices; Final, FDA May 11, 2005
#### J) Conclusion:
Invia, LLC believes that the Corridor4DM v2010 is substantially equivalent to the predicate devices based on intended usage, technology comparison and system performance. Corridor4DM v2010 validation testing showed no new issues of safety and effectiveness when compared to predicate devices.
April 26, 2010
Corridor4DM v.2010
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Image /page/4/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the eagle.
#### DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring. MD 20993-0002
# ANS 04 2010
INVIA, LLC % Mr. F. David Rothkopf President MEDIcept, Inc. 200 Homer Ave ASHLAND MA 01721
Re: K101279
Trade/Device Name: Corridor4DM v2010 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ, KPS, and JAK Dated: April 26, 2010 Received: May 6, 2010
#### Dear Mr. Rothkopf:
We have reviewed your 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 I frease of acrease 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 or mr) 1 vith 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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Enclosure
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 510(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,
Donald J. Trump
Donald J. St.Pierre Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
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# Indications for Use
510(k) Number (if known): K101279
AUG 0 4 2010
Device Name: Corridor4DM v2010
Indications for Use:
INVIA's Corridor4DM v2010 application is intended to provide processing quantification, and multidimensional review of the biodistribution of radionuclides in the body using planar and tomographic images. The application performs quantitative measurements of tracer uptake over time to aid in the interpretation of myocardial perfusion tomographic images. Cardiac CT interpretation and calcium quantification are optional features that are integrated into Corridor4DM (SPECT-CT and PET-CT). The calcium scoring package is a non-invasive diagnostic tool that can be used to evaluate the calcified plaques in the corònary arteries, a risk factor for coronary artery disease. Co-registration or fusion of volumetric data (ECT and/or CT) is provided as a quality control for the identification of structures where correlative spatial information is necessary for a diagnostic interpretation.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division of Radiological D Office of In Vitro
510K K101279
Page 1 of 1
Corridor4DM v2010
INVIA 510(k)
005
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.
