K021021 · Siemens Medical Solutions USA, Inc. · JAA · Jun 6, 2002 · Radiology
Device Facts
Record ID
K021021
Device Name
MODULAR ANGIOGRAPHY SYSTEM AXIOM ARTIS
Applicant
Siemens Medical Solutions USA, Inc.
Product Code
JAA · Radiology
Decision Date
Jun 6, 2002
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 892.1650
Device Class
Class 2
Indications for Use
AXIOM Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Procedures that can be performed with the AXIOM Artis family include cardiac angiography, neuroangiography, general angiography, operating room angiography, multipurpose angiography and radiographic/fluoroscopic procedures e.g. Gastro-intestinal imaging, Skeletal imaging etc. AXIOM Artis can also support the acquisition of position triggered imaging for spatial data synthesis. When equipped with the AXIOM OR table from the Koordinat Table family, the Modular Angiography System is suitable for angiographic procedures in operating rooms.
Device Story
AXIOM Artis is a modular angiography system utilizing a Trixell Pixium 4800 amorphous silicon flat panel detector for X-ray imaging. Designed for single or biplane diagnostic and interventional procedures, it supports cardiac, neuro, and general angiography, as well as radiographic/fluoroscopic imaging. The system captures X-ray signals, which are processed for diagnostic review on optional flat-screen monitors. Operated by trained healthcare professionals in clinical or operating room settings, the system assists in clinical decision-making by providing high-resolution visualization of vascular and anatomical structures. It supports position-triggered imaging for spatial data synthesis. The device benefits patients by enabling minimally invasive interventional procedures and precise diagnostic imaging.
Clinical Evidence
Bench testing only. No clinical data provided.
Technological Characteristics
Modular X-ray angiography system featuring a Trixell Pixium 4800 amorphous silicon flat panel detector. System components are largely commercially available or minor modifications of existing Siemens systems. Supports single and biplane configurations. Includes optional flat-screen monitors for diagnostic review. Adheres to industry standards for electrical, mechanical, and radiation safety.
Indications for Use
Indicated for patients requiring diagnostic imaging and interventional procedures, including cardiac, neuro, general, and multipurpose angiography, as well as radiographic/fluoroscopic procedures (e.g., GI, skeletal imaging). Suitable for use in operating rooms when configured with the AXIOM OR table.
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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## Jun -6 2002
510(K) SUMMARY
## Submitted by: Siemens Medical Solutions USA, Inc. 186 Wood Avenue South Iselin, NJ 08830
## March 22, 2002
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92.
Contact Person 1.
Ms. Sandra Robinson Phone: (732) 321-3243 Fax: (732) 321-4841
2. Device Name and Classification
Trade Name: Modular Angiography System AXIOM Artis with Flat Panel Detector Classification Name: Angiographic X-ray System Classification Panel: Radiology CFR Section: 21 CFR § 892.1600 Device Class: Class II Device Cade: 901ZI
#### 3. Intended Use
AXIOM Artis is a dedicated angiography system developed for single and biplane diagnostic imaging and interventional procedures.
AXIOM Artis can support the acquisition of position triggered imaging for spatial data synthesis. When equipped with the AXIOM OR table from the Koordinat Table family, the Modular Angiography System is suitable for angiographic procedures in operating rooms.
#### 4. Substantial Equivalence
AXIOM Artis with Dynamic Flat Panel Detector is substantially equivalent to the current, commercially available Siemens AXIOM Artis and the GB Angiographic systems, the INNOVA 2000. The Flat Panel detector Trixell Pixium 4800 is a joint venture development between Thales, Philips and Siemens. It may be used with the Siemens AXIOM Artis and the Philips Integris Allura.
The AXIOM Artis was described in premarket notification K010721 and received FDA clearance on March 30, 2001. The Philips Integris Allura Flat Detector system with the Trixell Pixium 4800 was described in premarket notification (510(k) number not yet published) and received FDA clearance on March 15, 2002. INNOVA 2000 was described in premarket notification K993037 and received FDA clearance on February 14, 2000.
Information that substantiates this claim of equivalence is provided throughout this 510/k) submission and specific equivalence information is provided in Attachment S.
#### ട. Device Description
The AXIOM Artis Modular Angiography System with Dynamic Flat Panel detector is designed as a set of components that may be combined into different configurations to provide specialized angiography systems. It is basically equal to the AXIOM Artis Modular Angiography System family with all its components. A new Flat Panel detector has been adapted to the system. The detector is comprised of a large area amorphous silicon layer. Flat screen monitors for diagnostic review are optional available.
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## 6. Summary of Technological Characteristics of the Principal Device as Compared with the Predicate Device
Many of the components used in AXIOM Artis with Dynamic Flat Panel detector are either commercially available with current Siemens systems or include minor modifications to existing components.
#### General Safety and Effectiveness Concerns 7.
Instructions for use are included within the device labeling and the information provided will enable the trained healthcare professional to operate the device in a safe and efficacious manner. Furthermore the operators are health care professionals familiar with and responsible for the X-ray examinations to be performed. To minimize electrical, mechanical and radiation hazards, Siemens adheres to recognized and established industry practice, and all equipment is subject to final performance testing.
#### Substantial Equivalence 8.
In the opinion of Siemens Medical Solutions USA, Inc., the hardware and software documentation and the substantial equivalence comparison matrix proves that the AXIOM Artis with Flat Panel Detector is substantially equivalent to the Siemens Medical Solutions USA, Inc. predicate Angiography systems - the AXIOM Artis family of Modular Angiography systems, the Philips Integris Allura Flat Detector system and the GE's Medical System INNOVA 2000.
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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The logo consists of a symbol on the left and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" on the right. The symbol is a stylized representation of a human figure, and the text is in a clear, sans-serif font.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Ms. Kathleen Rutherford Manager, Regulatory Submissions Siemens Medical Solutions USA, Inc. 186 Wood Avenue South ISELIN NJ 08830
AUG 2 0 2013
Re: K021021
Trade/Device Name: Modular Angiography System AXIOM Artis with Flat Panel Detector Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: JAA and IZI Dated: March 22, 2002 Received: March 29, 2002
Dear Ms. Rutherford:
This letter corrects our substantially equivalent letter of June 6. 2002.
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 Mav 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 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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# CONFIDENTIAL
# Attachment 1
# Indications For Use
510(k) Number (if known): Device Name: __ Modular Angiography System AXIOM Artis with Flat Panel Detector
Indications for Use:
AXIOM Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures.
Procedures that can be performed with the AXIOM Artis family include cardiac angiography, neuroangiography, general angiography, operating room angiography, multipurpose angiography and radiographic/fluoroscopic procedures e.g. Gastro-intestinal imaging, Skeletal imaging etc. AXIOM Artis can also support the acquisition of position triggered imaging for spatial data synthesis.
The intended use and indications for use of the Modular Angiography System AXIOM Artis with Flat Panel Detector as described in its labeling have not changed from its predicate device AXIOM Artis with the image intensifier.
(Please do not write below this line - continue on another page if needed)
Concurrence of the CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR Over-The-Counter Use
(Per 21 CFR 801.109)
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K021021
<sup>510(</sup>k) for Siemens AXIOM Flat Panel Detector 03/22/02
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.
