PHILIPS BUCKY VISION

K982795 · Philips Medical Systems, Inc. · MQB · Nov 24, 1998 · Radiology

Device Facts

• Record ID: K982795
• Device Name: PHILIPS BUCKY VISION
• Applicant: Philips Medical Systems, Inc.
• Product Code: MQB · Radiology
• Decision Date: Nov 24, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1680
• Device Class: Class 2

Indications for Use

The Philips BuckyVision is intended for use in general radiographic examinations and applications wherever conventional screen-film systems may be used (excluding fluoroscopy, angiography, and mammography).

Device Story

Philips BuckyVision is a general-purpose digital X-ray system. It utilizes a TRIXELL PIXIUM-4600 Solid State X-ray Imager (SSXI) to convert X-rays directly into electrical signals. These signals undergo processing at a workstation for image management, export, and printing. The system integrates with standard Philips bucky Diagnost components, including X-ray tubes, generators, and collimators. Operated by radiology staff in clinical settings, the device provides digital images on a CRT monitor or laser-imager. This digital workflow replaces traditional screen-film radiography, offering immediate image availability and processing capabilities to support clinical diagnostic decision-making.

Clinical Evidence

Bench testing only.

Technological Characteristics

System utilizes TRIXELL PIXIUM-4600 Solid State X-ray Imager (SSXI) for direct X-ray to electrical signal conversion. Includes X-ray tube, generator, collimator, and workstation. Connectivity provided via workstation for image processing, worklist management, and printing. Operates as a stationary diagnostic X-ray system.

Indications for Use

Indicated for general radiographic examinations in patients requiring diagnostic imaging, excluding fluoroscopy, angiography, and mammography. Intended for use wherever conventional screen-film systems are utilized.

Regulatory Classification

Identification

A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. 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). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary 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.

Predicate Devices

• Philips bucky Diagnost System with Radiographic Screen Film Systems (K945287)
• Sterling Diagnostic Imaging Direct Radiography™ device (K973206)
• Philips Thoravision (K931071)

Submission Summary (Full Text)

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NOV 24 1998

Image /page/0/Picture/1 description: The image shows the Philips logo and brand name. The logo is a shield-like shape with a circle inside, containing wavy lines and stars. Next to the logo, the word "PHILIPS" is written in bold, sans-serif font. Below the brand name, there is a handwritten alphanumeric code "K982795".

# Philips Medical Systems

# 510(k) Summary of Safety and Effectiveness

| Company Name: | Philips Medical Systems North America Company |
|----------------------|----------------------------------------------------------------------------------------|
| Address: | 710 Bridegeport Avenue<br>Shelton, CT 06484 |
| Contact Person: | Peter Altman |
| Telephone Number: | 203-926-7031 |
| Prepared (date): | June 15, 1998 |
| Device Name: | Philips BuckyVision |
| Classification Name: | Stationary Diagnostic X-ray System using Digital Solid<br>State X-ray Imaging Detector |
| Common/Usual Name: | General Purpose X-ray System |
| Predicate Device: | Philips bucky Diagnost / Screen Film System |

Philips Medical Systems
710 Bridgestics Archives of Company
Pro Bridges Bronners Arcompany
Pro Box Bell Bromers Court 06484-0917
Fax: [phone]

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### System Description:

The Philips BuckyVision System uses the new x-ray imaging technology ( Solid State X-ray Imager, SSXI ), that converts x-rays directly into electrical signals which can, after appropriate processing, be displayed on a crt-monitor for medical diagnosis or printed out on laser-imager.

The basis of the system is a standard Philips bucky Diagnost System with additional TRIXELL PIXIUM-4600 SSXI connected to a Philips Thoravision-like workstation for worklist-managment, image-processing, image-exporting, and printing. The complete system includes additional subsystems and components, like X-raytube(s), X-ray-generator, collimator, and optionally, a wall bucky with SSXI.

#### Intended Use:

The Philips BuckyVision is intended for use in general radiographic examinations and applications wherever conventional screen-film systems may be used (excluding fluoroscopy, angiography, and mammography).

### Substantial Equivalence Information:

The Philips Bucky Vision is of comparable type and substantially equivalent to:

| the Philips bucky Diagnost System<br>with Radiographic Screen Film Systems, | 510(k) Number : | K945287. |
|-----------------------------------------------------------------------------|-----------------|----------|
| the Sterling Diagnostic Imaging Direct Radiography™ device: | 510(k) Number : | K973206 |
| and the Philips Thoravision | 510(k) Number : | K931071. |

Therefore the Philips Bucky Vision system complies to the same or equivalent standards and has the same intended use as the predicate device.

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure, with three overlapping profiles suggesting a sense of community and support. The profiles are rendered in a simple, flowing line style. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" is arranged in a circular pattern around the central figure, indicating the department's name and national affiliation.

## NOV 2 4 1998

Peter Altman Director of Regulatory Affairs Philips Medical Systems 710 Bridgeport Avenue P. O. Box 860 Shelton, Connecticut 06484-0917 Re:

Food and Drug Administration 9200 Corporate Boulevard K982795 K982795
Philips Bucky Vision Family Comprising: bucky Diagnost TH (+SSXI) with bucky Diagnost CS2: bucky Diagnost TH (+SSXI) with bucky Diagnost CS4: bucky Diagnost VT (+SSXI) with bucky Diagnost CS2: and bucky Diagnost VT (+SSXI) with bucky Diagnost CS4. Dated: November 12, 1998 Received: November 13, 1998 Regulatory class: II 21 CFR 892.1680/Procode: 90 MOB 21 CFR 892,1680/Prodode: 90 KPR

#### Dear Mr. Altman:

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 to devices marketed in interstate commerce prior to May 28, 1976, the enacument 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 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 either class II (Special Controls) or 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 531 through 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 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 Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone] for Radiology devices, or 594-4613 for Ear. Nose and Throat devices. 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 at [phone].

Sincerely yours.

William Yin
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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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Unknown

Philips BuckyVision Device Name :

Indications For Use :

The Philips BuckyVision is intended for use in general radiographic examinations and applications wherever conventional screen-film systems may be used (excluding fluoroscopy angiography, and mammography).

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K982795/51

Prescription Use
( Per 21 CFR 801.109
OR
Over-The-Counter Use **__**

(Optional Format 1-1