FLUOROSPOT COMPACT

K982028 · Siemens Medical Solutions USA, Inc. · JAA · Jul 14, 1998 · Radiology

Device Facts

• Record ID: K982028
• Device Name: FLUOROSPOT COMPACT
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: JAA · Radiology
• Decision Date: Jul 14, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1650
• Device Class: Class 2

Intended Use

The Fluorospot Compact digital imaging system, is an optional integral component of a radiographic/fluoroscopic x-ray system, and as such it is not considered a stand alone device. The Fluorospot Compact is intended for use with x-ray systems to digitally acquire, record and display radiographic images. The Fluorospot Compact enables the trained healthcare professional to consistently acquire high quality images for fluoroscopic examinations with contrast medium, urological examinations as well as vascular and non-vascular procedures.

Device Story

Fluorospot Compact is a PC-based digital imaging system integrated into radiographic/fluoroscopic x-ray systems. It captures 10-bit digital images (1024x1024 format) from the image intensifier/TV chain output of conventional x-ray systems. Operated by trained healthcare professionals in exam or control rooms, it allows real-time display, acquisition, and storage of images without interrupting procedures for film changes. The system supports clinical decision-making by providing high-quality digital visualization for fluoroscopic, urological, and vascular/non-vascular procedures, replacing or supplementing traditional film-based imaging.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use compared to predicate devices.

Technological Characteristics

PC-based digital imaging system; 10-bit acquisition; 1024x1024 image format; integrates with conventional over-table/under-table x-ray systems (e.g., Sireskop SX, Siregraph CX); utilizes image intensifier/TV chain input.

Indications for Use

Indicated for use by trained healthcare professionals in conjunction with radiographic/fluoroscopic x-ray systems to acquire, record, and display images for fluoroscopic examinations with contrast medium, urological examinations, and vascular/non-vascular procedures.

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

• Fluorospot T.O.P (K961871)
• Fluorospot H (Version 2) (K914525)
• Fluorospot H (Version 1) (K911082)

Submission Summary (Full Text)

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**SIEMENS**

K982028

## APPENDIX 1

JUL 1 4 1998

510(k) Summary Fluorospot Compact

Submitted by:

Siemens Medical Systems, Inc. 186 Wood Avenue South Iselin, NJ 08830

June 8, 1998

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.

#### 1. Contact Person:

Ms. Malgorzata Stanek Phone: [phone] Fax: [phone]

#### Device Name and Classification: 2.

Trade Name: Classification Name: CFR Section: Device Code:

Fluorospot Compact Image Intensified Fluoroscopic X-ray System 21 CFR 8892.1650. Class II 90JAA

" "

#### 3. Substantial Equivalence:

The Fluorospot Compact is substantially equivalent to the following Siemens Medical Systems' devices:

- 1) Fluorospot T.O.P K961871, cleared by FDA on July 31, 1996
- 2) Fluorospot H (Version 2) K914525, cleared by FDA on November 19, 1991

Fluorospot H (Version 1) K911082, cleared by FDA on May 1, 1991

#### 4. Device Description:

The Fluorospot Compact is a PC-based, 10 bit acquisition digital imaging system where images are acquired in 10242 format. It can be configured with conventional overtable/under-table x-ray systems (e.g. commercially available Sireskop SX and Siregraph CX). Configuring the conventional systems with Fluorospot Compact provides the

# Siemens Medical Systems, Inc.

Sales and Service

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# SIEMENS

systems with multi-functional use capability, thus allowing trained healthcare professionals to perform x-ray imaging using conventional film or digital imaging. Upon acquiring digital images, the user can display them on the live monitor in the exam room, as well as the control room for review. Multiple digital image acquisition and storage is possible without interrupting the procedure to change film.

#### న. Intended Use of the Device:

The Fluorospot Compact digital imaging system, is an optional integral component of a radiographic/fluoroscopic x-ray system, and as such it is not considered a stand alone device. The Fluorospot Compact is intended for use with x-ray systems to digitally acquire, record and display radiographic images. The Fluorospot Compact enables the trained healthcare professional to consistently acquire high quality images for fluoroscopic examinations with contrast medium, urological examinations as well as vascular and non-vascular procedures.

### Summary of Technological Characteristics of the Device Compared to the Predicate 6. Device:

The Fluorospot Compact has the same technological characteristics as the predicates Fluorospot T.O.P. and Fluorospot H. They utilize PC based technology to acquire, store and post process images from the image intensifier/TV chain output of an image intensified fluoroscopic system.

Kathleen Rutherford

Kathleen Rutherford Manager, Regulatory Submissions Siemens Medical Systems, Inc.

## Siemens Medical Systems, Inc.

Sales and Service

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186 Wood Avenue South Iselin, NJ 08830

Tel: [phone] Fax: [phone]

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 4 1998

Malgorzata Stanek Siemens Medical Systems, Inc. 186 Wood Avenue South Iselin, NJ 08830

Re:

K982028

Fluorospot Compact Dated: June 8, 1998 Received: June 9, 1998 Regulatory class: II 21 CFR 892.1650/Procode: 90 JAA

Dear Mr. Stanek:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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, against misbranding and adulteration.

If your device is classified (see above) into either class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Resulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (2) CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predication 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 Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address "http://www.fda.gov/cdrb/dsmaldsmamain.html".

Sincerely yours,

Kilian Yih

Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## APPENDIX 2

## INDICATIONS FOR USE

510(k) Number (if known): Fluorospot Compact Device Name:

## Indications For Use:

The Fluorospot Compact digital imaging system, is an optional integral component of a radiographic/fluoroscopic x-ray system, as such it is not considered a stand alone device. The Fluorospot Compact is intended for use with x-ray systems to digitally acquire, record and display radiographic images. The Fluorospot Compact enables the trained healthcare professional to consistently acquire high quality images for fluoroscopic examinations with contrast medium, urological examinations as well as vascular and non-vascular procedures.

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Concurrence of the CDRH, Office of Device Evaluation (ODE) .

・・・・

David A. Ingram

(Division Sign-Off) Division of Reproductive, Abdominal, EN and Radiological Devic

510(k) Number K982028

V Prescription Use OR Over-The-Counter Use (Per 21 CFR 801.109)