INFINIX-I INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000V
K101868 · Toshiba America Medical Systems, In.C · OWB · Sep 7, 2010 · Radiology
Device Facts
Record ID
K101868
Device Name
INFINIX-I INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000V
Applicant
Toshiba America Medical Systems, In.C
Product Code
OWB · Radiology
Decision Date
Sep 7, 2010
Decision
SESE
Submission Type
Special
Regulation
21 CFR 892.1650
Device Class
Class 2
Indications for Use
This device is a digital x-ray system configured for use as a diagnostic x-ray angiography system. This x-ray angiography system is used for diagnostic and interventional procedures for cardiac blood vessels, cerebral blood vessels, abdominal blood vessels and lower extremities. This device is a digital radiography/fluoroscopy system used in a diagnostic angiography configuration. This system is indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen and lower extremities. 3D Road-mapping function to assist in the planning and execution of interventional procedures
Device Story
Digital x-ray angiography system (Infinix CFi/VFi) utilizes x-ray generator, support arms, and solid-state detectors to acquire fluoroscopic/radiographic images. System includes 3D Road-mapping function, an extension of existing 2D Road-mapping; overlays fluoroscopic images onto DSA (Digital Subtraction Angiography) images on system monitor. Used in clinical settings by physicians for planning and executing interventional procedures. Output assists clinicians in visualizing vascular anatomy during minimally invasive interventions, potentially improving procedural accuracy and patient outcomes.
Clinical Evidence
No clinical data provided. Substantial equivalence is based on bench testing, risk management, and adherence to recognized safety standards (IEC 60601-1, IEC 60601-2-32, IEC 60601-2-28) and Federal Diagnostic X-ray Equipment Standards (21 CFR 1020).
Technological Characteristics
Digital x-ray angiography system; solid-state detectors; x-ray generator; support arms; computer-based image processing. Complies with IEC 60601-1, IEC 60601-2-32, IEC 60601-2-28, and 21 CFR 1020. Software-based 3D Road-mapping overlay functionality.
Indications for Use
Indicated for diagnostic and interventional angiography procedures of cardiac, cerebral, abdominal, and lower extremity blood vessels. Prescription use only.
Regulatory Classification
Identification
An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
Special Controls
*Classification.* Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
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## Toshiba America Medical Systems, Inc. Pre-Market Notification 510(k) for INFX-8000V w/3D Roadmapping
| 510(k) Summary | | K101868 |
|---------------------------------------|----------------------------------------------------------------------------------------------------------|--------------|
| Date: | June 30, 2010 | SEP. 07 2010 |
| Submitter's Name: | Toshiba America Medical Systems, Inc. | |
| Submitter's Address: | P.O. Box 2068, 2441 Michelle Drive,<br>Tustin, CA 92781-2068 | |
| Submitter's Contact: | Paul Biggins, Director Regulatory Affairs<br>(714)730-5000 | |
| Establishment Registration<br>Number: | 2020563 | |
| Device Proprietary Name: | INFX-8000V (Infinix CFi and Infinix VFi) | |
| Common Name: | Electrostatic Fluoroscopic x-ray System)<br>[Fed. Reg. No. 892.1650, Pro. Code: 90MQB] | |
| Regulatory Class: | II (per 21 CFR 892.1650) | |
| Performance Standard: | 21 CFR Subchapter J,<br>Federal Diagnostic X-ray Equipment Standard | |
| Predicate Devices | Toshiba, INFX-8000V<br>GE Innova 2100,3100, 4400 w/Innova 3D or InnovaSpin<br>Siemens In Space 3D Option | |
| Reason For Submission | Addition of 3D Road-mapping Function | |
#### Description of this Device:
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These systems are single or dual plane systems that employ x-rays to obtain fluoroscopy or radiography images of the body. The system is comprised of a computer system, support arms that contain the tube and solid state detector (either one or two), x-ray generator and a patient table.
The 3D Road-mapping function is an extension of the already existing 2D Road-mapping function both of which overlay the fluoroscopic image on the DSA image on the system monitor.
#### Summary of Intended Uses:
This device is a digital x-ray system configured for use as a diagnostic x-ray angiography system. This x-ray angiography system is used for diagnostic and interventional procedures for cardiac blood vessels, cerebral blood vessels, abdominal blood vessels and lower extremities.
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## Toshiba America Medical Systems, Inc. Pre-Market Notification 510(k) for INFX-8000V w/3D Roadmapping
### Technological Characteristics:
-
This device employs similar materials and processes as found in the predicate device. The device produces ionizing radiation that is employed to generate fluoroscopic and radiographic images of the anatomy.
#### Safety and Effectiveness Concerns:
This device is designed and manufactured under the Quality System Regulations as outlined in 21 CFR § 820. All requirements of the Federal Diagnostic Equipment Standard, as outlined in 21 CFR § 1020,that apply to this device, will be met and reported via an initial report. Additionally this system is in conformance with the applicable parts of the IEC 60601-1 {applicable portions}; IEC 60601-2-32, and IEC 60601-2-28. - Medical Device Safety standards.
Furthermore, the system is subjected to a risk management , during the design stages to mitigate risks appropriately. The risks may be mitigated through hardware, software or user information as deemed appropriate by the level of risk and appropriate mitigation strategies.
#### Substantial Equivalence:
The INFX-8000V with 3D Road-mapping is of comparable type and substantially equivalent to:
Toshiba, INFX-8000V; K081852 GE, Innova 2100, 3100, 4400 w/Innova 3D or InnovaSpin; K054212 Siemens, In Space 3D Option; K011447
Therefore the INFX-8000V complies with the same or equivalent standards and has the same intended use as the predicate devices.
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## 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
Mr. Paul Biggins Director, Regulatory Affairs Toshiba America Medical Systems, Inc. 2441 Michelle Drive TUSTIN CA 92780
Re: K101868
Trade/Device Name: infx-8000v; Infinix CFi and Infinix-VFi Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB and JAA Dated: August 12, 2010 Received: August 13, 2010
Dear Mr. Biggins:
This letter corrects our substantially equivalent letter of September 7, 2010.
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.
JUL 30 2012
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 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,
Janine M. Morris
Acting 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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K101868
## Toshiba America Medical Systems, Inc. Pre-Market Notification 510(k) for INFX-8000V w/ 3D Road-mapping
# Indications for Use
SEP.0772010
510(k) Number (if known):
Device Name: INFX-8000V; Infinix-CFi and Infinix- VFi
Indications for Use:
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This device is a digital radiography/iluoroscopy system used in a diagnostic anglography configuration. This system is indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen and lower extremities.
3D Road-mapping function to assist in the planning and execution of interventional procedures
× Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
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6
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.
