STERLING DIAGNOSTIC IMAGING DIRECT RADIOGRAPHY

K973206 · Sterling Diagnostic Imaging, Inc. · MQB · Dec 4, 1997 · Radiology

Device Facts

• Record ID: K973206
• Device Name: STERLING DIAGNOSTIC IMAGING DIRECT RADIOGRAPHY
• Applicant: Sterling Diagnostic Imaging, Inc.
• Product Code: MQB · Radiology
• Decision Date: Dec 4, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1680
• Device Class: Class 2

Indications for Use

The Direct Radiography™ device provides a digital image capture capability for conventional radiographic examinations (excluding fluoroscopic, angiographic, and mammographic applications). The device has application wherever conventional screen-film systems are currently used.

Device Story

Device captures and converts conventional projection X-ray images into digital format; replaces traditional film/wet chemical processing with a digital array. Input: X-ray radiation; Output: digital images for preview, diagnostic viewing, and printing. Used in clinical settings for conventional radiography. Digital data transmitted via network for review by clinicians. Benefits include elimination of chemical processing and transition to digital workflow.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Solid state X-ray imaging device; utilizes a digital array for electronic image capture; produces digital output; networked for image transmission and printing.

Indications for Use

Indicated for conventional radiographic examinations where screen-film systems are used. Excludes fluoroscopic, angiographic, and mammographic applications. Patient population not specified.

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

• Radiographic Film (892.1840)
• Radiographic Intensifying Screen (892.1960)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo for Sterling Diagnostic Imaging. The logo consists of the word "STERLING" in large, bold letters, with the registered trademark symbol next to the "G". Below the word "STERLING" is the phrase "Diagnostic Imaging" in a smaller font. The alphanumeric code "K973206" is located below the company name.

## 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

س

This summary of 510(k) safety and effectiveness information is being submitted in DEC - 4 1997 accordance with the requirements of SMDA 1990 and 21CFR 807.92,

| Submitter's Name: | Elaine H. Kindell<br>[phone]<br>Sterling Diagnostic Imaging, Inc.<br>P. O. Box 6020<br>Route 896, Building 600<br>Glasgow Business Community<br>Newark, DE 19714-6020<br>Fax# [phone] |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date of Preparation: | August 22, 1997 |
| Name of Product: | Sterling Diagnostic Imaging Direct RadiographyTM |
| FDA Classification Name: | Solid State X-ray Imaging Device - 90 MBQ |
| Predicate Device: | Radiographic Film (892.1840)<br>Radiographic Intensifying Screen (892.1960) |
| Device Description: | The Sterling Diagnostic Imaging Direct<br>RadiographyTM device is used to directly capture<br>and convert conventional projection X-ray images<br>to digital images. A sub-sampled image can be<br>displayed on a preview monitor for viewing. The<br>diagnostic image can be transmitted through a<br>digital network for diagnostic viewing and printing.<br>The device provides digital image capture for<br>conventional radiographic examinations (excluding<br>fluoroscopic, angiographic, and mammographic<br>applications). The Direct RadiographyTM device<br>differs from traditional X-ray systems in that instead<br>of exposing a film for subsequent wet chemical<br>processing to create a hardcopy image, a device<br>called a digital array is used to capture the image in<br>electronic form. The digital data are then used to<br>produce hardcopy and softcopy images. |

{1}------------------------------------------------

The Direct Radiography™ device provides a digital Intended Use: image capture capability for conventional radiographic examinations (excluding fluoroscopic, angiographic, and mammographic applications). The device has application wherever conventional screen-film systems are currently used. The Sterling Direct Radiography™ device uses an Comparison to Predicate electronic readout of an image while conventional Device: screen-film systems require chemical processing to produce an image. The Sterling Direct Radiography™ device produces a digital image while conventional screen-film systems produce an analog image.

Both systems are used for conventional Comments on Substantial Equivalence: radiographic examinations.

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows a logo for the Department of Health & Human Services. The logo consists of the department's name arranged in a circular fashion around a symbol. The symbol is a stylized representation of a human figure, with three overlapping profiles suggesting a sense of community or interconnectedness. The logo is in black and white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Elaine H. Kindell Regulatory Affairs Manager STERLING™ Diagnostic Imaging, Inc. Glasgow Business Community P.O. Box 6020 Newark, DE 19714-6020

Re: K973206 Sterling Diagnostic Imaging Direct RadiographyTM Dated: November 24, 1997 Received: November 25, 1997 Unclassified/Procode: 90 MQB

DEC - 4 1997

Dear Ms. Kindell:

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 interstate in interstate commerce prior to May 28, 1976, the enactment date of the Medical Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, 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 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 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 531 through 542 of the Act for devices under 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]. Additionally, for question 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/cdrh/dsmamain.html".

Sincerely yours,

h)liau Yu
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

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for Sterling Diagnostic Imaging. The logo consists of the word "STERLING" in large, bold letters, with the registered trademark symbol next to the "G". Below the word "STERLING" is the phrase "Diagnostic Imaging" in a smaller font. The alphanumeric code "K973206" is located below the company name.

## 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

س

This summary of 510(k) safety and effectiveness information is being submitted in DEC - 4 1997 accordance with the requirements of SMDA 1990 and 21CFR 807.92,

| Submitter's Name: | Elaine H. Kindell<br>[phone]<br>Sterling Diagnostic Imaging, Inc.<br>P. O. Box 6020<br>Route 896, Building 600<br>Glasgow Business Community<br>Newark, DE 19714-6020<br>Fax# [phone] |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date of Preparation: | August 22, 1997 |
| Name of Product: | Sterling Diagnostic Imaging Direct RadiographyTM |
| FDA Classification Name: | Solid State X-ray Imaging Device - 90 MBQ |
| Predicate Device: | Radiographic Film (892.1840)<br>Radiographic Intensifying Screen (892.1960) |
| Device Description: | The Sterling Diagnostic Imaging Direct<br>RadiographyTM device is used to directly capture<br>and convert conventional projection X-ray images<br>to digital images. A sub-sampled image can be<br>displayed on a preview monitor for viewing. The<br>diagnostic image can be transmitted through a<br>digital network for diagnostic viewing and printing.<br>The device provides digital image capture for<br>conventional radiographic examinations (excluding<br>fluoroscopic, angiographic, and mammographic<br>applications). The Direct RadiographyTM device<br>differs from traditional X-ray systems in that instead<br>of exposing a film for subsequent wet chemical<br>processing to create a hardcopy image, a device<br>called a digital array is used to capture the image in<br>electronic form. The digital data are then used to<br>produce hardcopy and softcopy images. |

{4}------------------------------------------------

The Direct Radiography™ device provides a digital Intended Use: image capture capability for conventional radiographic examinations (excluding fluoroscopic, angiographic, and mammographic applications). The device has application wherever conventional screen-film systems are currently used. The Sterling Direct Radiography™ device uses an Comparison to Predicate electronic readout of an image while conventional Device: screen-film systems require chemical processing to produce an image. The Sterling Direct Radiography™ device produces a digital image while conventional screen-film systems produce an analog image.

Both systems are used for conventional Comments on Substantial Equivalence: radiographic examinations.

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image shows a logo for the Department of Health & Human Services. The logo consists of the department's name arranged in a circular fashion on the left side of the image. To the right of the text is a symbol that appears to be an abstract representation of a human figure or a stylized design. The image is in black and white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Elaine H. Kindell Regulatory Affairs Manager STERLING™ Diagnostic Imaging, Inc. Glasgow Business Community P.O. Box 6020 Newark, DE 19714-6020

Re: K973206 Sterling Diagnostic Imaging Direct RadiographyTM Dated: November 24, 1997 Received: November 25, 1997 Unclassified/Procode: 90 MQB

DEC - 4 1997

Dear Ms. Kindell:

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 interstate in interstate commerce prior to May 28, 1976, the enactment date of the Medical Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, 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 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 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 531 through 542 of the Act for devices under 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]. Additionally, for question 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/cdrh/dsmamain.html".

Sincerely yours,

h)liau Yu
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

{6}------------------------------------------------

## Indications Statement

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Sterling Diagnostic Imaging Direct Radiography™ Device Name:

Indications for Use:

The Direct Radiography™ device provides a digital image capture capability for conventional radiographic examinations (excluding fluoroscopic, angiographic, and mammographic applications). The device has application wherever conventional screen-film systems are currently used.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | X | OR | Over-The-Counter Use |
|--------------------------|---|----|----------------------|
| (Per 21 CFR 801.109) | | | |
| (Optional Format 1-2-96) | | | |

(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number ..

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