K040066 · Siemens Medical Solutions USA, Inc. · OXO · Feb 12, 2004 · Radiology
Device Facts
Record ID
K040066
Device Name
SIREMOBILE C06
Applicant
Siemens Medical Solutions USA, Inc.
Product Code
OXO · Radiology
Decision Date
Feb 12, 2004
Decision
SESE
Submission Type
Special
Regulation
21 CFR 892.1650
Device Class
Class 2
Attributes
Pediatric
Indications for Use
The Siremobil C06 is a mobile x-ray system intended for use in operating room, traumatology, endoscopy, intensive care station, pediatrics, ambulatory patient care and in veterinary medicine. The Siremobil 06 can operate in six different modes: Digital Radiography, Fluoroscopy, Pulsed Fluoroscopy, Cassette Exposures, Digital Subtraction, and Roadmapping, which are necessary in performing wide variety of clivical procedures, such as intraoperative bile duct display, fluoroscopic display of intra-medullary nail implant in various positions, low dose fluoroscopy in pediatrics, fluoroscopic techniques utilized in pain therapy and positioning of catheters and probes.
Device Story
Mobile C-arm X-ray system; includes high-frequency generator, X-ray tube, image intensifier, TV camera, film cassette attachment, laser target devices, and monitor trolley. Operates in digital radiography, fluoroscopy, pulsed fluoroscopy, subtraction, and roadmapping modes. Used in OR, trauma, endoscopy, ICU, and veterinary settings by clinicians. Inputs include X-ray radiation; outputs include real-time fluoroscopic or static radiographic images displayed on flat-screen monitors. Digital storage system manages image data. Uninterruptible power supply protects data during outages. Assists physicians in surgical guidance, implant positioning, and interventional procedures; improves clinical workflow and patient outcomes through real-time visualization.
Clinical Evidence
Bench testing only. No clinical data provided.
Technological Characteristics
Mobile C-arm X-ray system. High-frequency generator, X-ray tube, image intensifier. 1024^2 digital image processing. Flat-screen monitors. Uninterruptible power supply. Modes: digital radiography, fluoroscopy, pulsed fluoroscopy, subtraction, roadmapping. Footswitch/hand switch control.
Indications for Use
Indicated for patients requiring intraoperative imaging, including pediatric and ambulatory populations, for procedures such as bile duct display, intra-medullary nail implantation, pain therapy, and catheter/probe positioning.
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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Kolooee
# FEB 1 2 2004
SIREMOBIL C 06 Submitted by:
510(K) SUMMARY
FOR THE
Siemens Medical Solutions USA, Inc. 51 Valley Stream Parkway Malvern, PA 19355
January 13, 2004
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. Nealie Hartman 51 Valley Stream Parkway Malvern, PA 19355 Phone: (610) 448-1769 Fax: (610) 448-1787
#### Device Name and Classification: 2.
Trade Name:
Classification Name: Classification Panel: CFR Section: Device Classification: Product Code:
Siremobil C 06 (C06 is internal project name, final name assignment will be determined prior to FDA clearance) Mobile X-Ray System Radiology 21 CFR §892.1720 Class II OYO & JAA
#### Substantial Equivalence: 3.
The Siremobil C 06 is substantially equivalent to the following devices:
| Predicate Device Name | 510(k) Number | Clearance Date | Comparable Properties |
|---------------------------|---------------|----------------|----------------------------------------------|
| Siemens Siremobil Compact | K963093 | 08/07/1996 | Hardware<br>Control Software<br>Intended use |
| Siemens Siremobil Iso-C | K973598 | 11/10/1997 | Hardware<br>Control Software<br>Intended use |
CONFIDENTIAI
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## Device Description: 4.
The Siremobil C 06 is a mobile x-ray system which consists of a mobile C-arm configured with a high frequency generator, X-ray tube assembly, image intensifier, TV camera, film cassotte attachment, laser target devices, electronics cabinet, a monitor trolley and digital image storage system which consists of the digital memory device, image monitor(s), and user interface. The system is equipped with a footswitch and a hand switch for radiation release in the five modes of operation: digital radiography, fluoroscopy, pulsed fluoroscopy, subtraction, and roadmapping.
### Intended Use of the Device: ર.
The Siremobil C06 is a mobile x-ray system intended for use in operating room, traumatology, endoscopy, intensive care station, pediatrics, ambulatory patient care and in veterinary medicine. The Siremobil 06 can operate in six different modes: Digital Radiography, Fluoroscopy, Pulsed Fluoroscopy, Cassette Exposures, Digital Subtraction, and Roadmapping, which are necessary in performing wide variety of clivical procedures, such as intraoperative bile duct display, fluoroscopic display of intra-medullary nail implant in various positions, low dose fluoroscopy in pediatrics, fluoroscopic techniques utilized in pain therapy and positioning of catheters and probes.
# Summary of Technological Characteristics of the Devices Compared to 6. the Predicate:
The Siremobil C 06 is a modification to the Siremobil Compact. Mechanically the changes are minor in design and style. The X-ray generator, X-ray tube and Image Intensifier are identical with the currently cleared product.
The imaging chain reflects the current standard of 10242 image processing and display with flat screen monitors. It was originally cleared with a stationary X-ray system (Uroskop Access) and is in clinical operation since more than 2 years. An uninterruntable power supply provides additional safety to image and demographic data in the event of a power outage.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of three human profiles facing right, rendered in blue lines. These profiles are stacked slightly offset from each other, creating a sense of depth. The profiles are encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Ms. Nealie Hartman Technical Specialist Regulatory Affairs Submissions Siemens Medical Solutions, Inc. USA 51 Valley Stream Parkway J-15 MALVERN PA 19355
MAY 22 2012
Re: K040066
Trade/Device Name: Siremobil CO6 Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OXO and JAA Dated: January 13, 2004 Received: January 13, 2004
Dear Ms. Hartman:
This letter corrects our substantially equivalent letter of November 14, 2011.
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 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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INDICATIONS FOR USE
| 510(k) Number (if known): | K040060 |
|---------------------------|---------------|
| Device Name: | SIREMOBIL C06 |
Indications For Use:
The Siremobil C06 is a mobile x-ray system intended for use in operating room, The Strenoon Coo is a moone it ve care station, pediatrics, ambulatory patient traumathogy, cheosophy, interaction of can operate in six different care and in vetermaly, Fluoroscopy, Pulsed Fluoroscopy, Cassette modes. Digital Radiographysn, and Roadmapping, which are necessary in performing wide variety of clinical procedures, such as intraoperative bile duct performing wide variety of of intra-medullary nail implant in various positions, low dose fluoroscopy in pediatrics, fluoroscopic techniques utilized in pain therapy and positioning of catheters and probes.
(Please do not write below this line - continue on another page if needed) ..............................................................................................................................................................................
Concurrence of the CDRH, Office of Device Evaluation (ODE)
OR Over-The-Counter Use_ Prescription Usc (Per 21 CFR 801.109)
David A. Lynn
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number .
Siemens Medical Solutions, Inc. USA Special 510(k) Siremobil C06
CONFIDENTIAL
Page 9
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.
