URF DIGITAL - OT

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

Intended 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.

Predicate Devices

• Siemens Siregraph T.O.P. 33 and 40 (K970734)

Submission Summary (Full Text)

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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: [phone] Fax: [phone]

### 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 [phone] or [phone] 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 |
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