K992660 · Siemens Medical Solutions USA, Inc. · OWB · Nov 5, 1999 · Radiology
Device Facts
Record ID
K992660
Device Name
URF DIGITAL - OT
Applicant
Siemens Medical Solutions USA, Inc.
Product Code
OWB · Radiology
Decision Date
Nov 5, 1999
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 892.1650
Device Class
Class 2
Attributes
Pediatric
Indications for Use
The URF Digital - OT is a device intended to visualize anatomical structures by converting a pattern of X-ray into a visible image through electronic amplification. The system has medical applications ranging from gastrointestinal examinations to cranial, skeletal, thoracic and lung exposures as well as examination of the urogenital tract. The units may also be used in lymphography, endoscopy, myelography, venography, pediatrics, arthrography, interventional radiology, digital angiography, and digital subtraction angiography (DSA).
Device Story
Universal fluoroscopic X-ray system for Digital Fluoro Radiography (DFR); utilizes undertable image intensifier. System components include patient support table, X-ray generator, X-ray tube, image intensifier, TV system, digital imaging system with CCD camera, and monitors. Operated via tableside or remote control console. Converts X-ray patterns into visible images through electronic amplification. Used in clinical settings for diagnostic and interventional procedures. Provides real-time visualization to assist physicians in clinical decision-making and procedural guidance.
Clinical Evidence
No clinical data provided; bench testing only.
Technological Characteristics
Universal fluoroscopic X-ray system; modular patient support table; X-ray generator; X-ray tube; image intensifier; TV system; digital imaging system with CCD camera; optional Bucky wall stand; optional ceiling-mounted support for second X-ray tube. Operates as a digital fluoroscopic imaging system.
Indications for Use
Indicated for visualization of anatomical structures via X-ray imaging. Applicable for gastrointestinal, cranial, skeletal, thoracic, lung, and urogenital tract examinations. Supports lymphography, endoscopy, myelography, venography, pediatrics, arthrography, interventional radiology, digital angiography, and digital subtraction angiography (DSA).
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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# ATTACHMENT 11
### 510(K) SUMMARY
K992660
# URF Digital - OT
Submitted by: Siemens Medical Systems, Inc. 186 Wood Avenue South Iselin, NJ 08830
August 6, 1999
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. Malgorzata Stanek Phone: (732) 321-3950 Fax: (732) 321-4841
### Device Name and Classification 2.
| Trade Name: | URF Digital - OT |
|-----------------------|---------------------------------------------|
| Classification Name: | Image Intensified Fluoroscopic X-ray System |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR § 892.1650 |
| Device Class: | Class II |
| Device Code: | 90JAA j0 WB |
#### Intended Use 3.
The URF Digital - OT is a device intended to visualize anatomical structures by converting a pattern of X-ray into a visible image through electronic amplification. The system has medical applications ranging from gastrointestinal examinations to cranial, skeletal, thoracic and lung exposures as well as examination of the urogenital tract. The units may also be used in lymphography, endoscopy, myelography, venography, pediatrics, arthrography, interventional radiology, digital angiography, and digital subtraction angiography (DSA).
#### Substantial Equivalence 4.
The URF Digital - OT is substantially equivalent to Siemens Siregraph T.O.P. 33 and 40 that are currently in commercial distribution. The Siregraph T.O.P. 33 and 40 were described in premarket notification K970734, which received FDA clearance on April 21, 1997.
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### 5. Device Description
URF Digital - OT is a universal fluoroscopic X-ray diagnostic system intended for use in Digital Fluoro Radiography (DFR) with an undertable image intensifier. The system is operated either via tableside control or via remote control console.
The URF Digital - OT is available in two versions, the URF Digital - OT TOP and the URF Digital - OT Comfort.
### 6. Summary of Technological Characteristics of the Principal Device as Compared with the Predicate Device
The URF Digital - OT has the same technological characteristics as the predicate Siregraph T.O.P 33 and 40. Like the Siregraph T.O.P 33 and 40, the URF Digital - OT consists of the basic system (patient support table) and standard system components (i.e. X-ray generator, X-ray tube, image intensifier, TV system, digital imaging system, monitors. optional Bucky wall stand and optional ceiling-mounted support for a second X-ray tube).
The Siregraph TOP and the URF Digital - OT differ such that, in the URF Digital - OT:
- The basic system and system stand are created from modular components for higher . flexibility.
- A new digital imaging system with CCD camera has been added. .
- The unit is configured with the latest commercially available system components. .
Kathleen Rutherford
Manager, Regulatory Submissions Siemens Medical Systems, Inc.
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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 consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circle around the eagle. The eagle is depicted in black, and the text is also in black. The logo is simple and recognizable, and it is often used to represent the U.S. Department of Health & Human Services.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Ms. Malgorzata Stanek Senior Technical Specialist Siemens Medical Systems, Inc. 186 Wood Ave., South ISELIN NJ 08830
MAY - 7 20:2
Re: K992660
Trade/Device Name: URF Digital-OT Image-Intensified Fluoroscopic X-ray System Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB and JAA Dated: August 6, 1999 Received: August 9, 1999
Dear Ms. Stanek:
This letter corrects our substantially equivalent letter of November 5, 1999.
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 that I Drines Intatutes and regulations administered by other Federal agencies. You must or my 1 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 pratice 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 whil anow you to begin marketing your interest of your device to a legally marketed nothleation. The I Driving of succion 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 11 you desire specific ad rice of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-007), production in the regulation entitled, "Misbranding by reference to premarket 5 150. Thise, productions and 2019). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to under the MDA regulation (27 Of RP art 000), product of ault.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 Tou may obtain other general incommarce. 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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### ATTACHMENT 1
### INDICATIONS FOR USE
510(k) Number (if known): K 992 660
URF Digital - OT Device Name: __________
ﺮ
Indications for Use:
The Siemens URF Digital - OT is intended to visualize anatomical structures by converting a pattern of X-ray into a visible image through electronic amplification. The system has medical applications ranging from gastrointestinal examinations to cranial, skeletal, thoracic and lung exposures, as well as examination of the urogenital tract. The URF Digital - OT may also be used in lymphography, endoscopy, myelography, venography, pediatrics, arthrography, interventional radiology, digital angiography, and digital subtraction angiography (DSA).
Concurrence of the CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|--------------------------------------------------------------------|---------|
| Division of Reproductive, Abdominal, ENT, and Radiological Devices | |
| 510(k) Number | K992660 |
| Prescription Use<br>(per 21 CFR 801.109) | OR Over-The-Counter Use |
|------------------------------------------|-------------------------|
|------------------------------------------|-------------------------|
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.
