(100 days)
892.1840, 892.1960
Not Found
No
The description focuses on digital image capture and conversion, with no mention of AI or ML for image analysis, interpretation, or other functions.
No
The device is used for capturing and converting X-ray images to digital form for diagnostic viewing, not for treating a condition. Its predicate devices are also diagnostic tools (Radiographic Film, Radiographic Intensifying Screen).
No
The device is described as an image capture and conversion system that produces digital images for diagnostic viewing, but it does not perform the diagnosis itself. Its intended use is to capture images for conventional radiographic examinations, replacing screen-film systems, which is an imaging function, not a diagnostic one.
No
The device description explicitly states it uses a "digital array" to capture the image in electronic form, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device function: The Direct Radiography™ device captures and converts conventional X-ray images to digital images. This process involves imaging the internal structures of the body using radiation, not analyzing biological samples.
- Intended Use: The intended use clearly states it's for "conventional radiographic examinations," which are imaging procedures, not laboratory tests.
- Device Description: The description focuses on the image capture and processing of X-ray data, not the analysis of biological specimens.
- Predicate Devices: The predicate devices listed are "Radiographic Film" and "Radiographic Intensifying Screen," which are components used in traditional X-ray imaging, not IVD devices.
Therefore, the Direct Radiography™ device falls under the category of medical imaging devices, specifically related to diagnostic radiology, rather than In Vitro Diagnostics.
N/A
Intended Use / 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.
Product codes
90 MBQ
Device Description
The Sterling Diagnostic Imaging Direct RadiographyTM device is used to directly capture and convert conventional projection X-ray images to digital images. A sub-sampled image can be displayed on a preview monitor for viewing. The diagnostic image can be transmitted through a digital network for diagnostic viewing and printing. The device provides digital image capture for conventional radiographic examinations (excluding fluoroscopic, angiographic, and mammographic applications). The Direct RadiographyTM device differs from traditional X-ray systems in that instead of exposing a film for subsequent wet chemical processing to create a hardcopy image, a device called a digital array is used to capture the image in electronic form. The digital data are then used to produce hardcopy and softcopy images.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Radiographic Film (892.1840), Radiographic Intensifying Screen (892.1960)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1680 Stationary x-ray system.
(a)
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.(b)
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.
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
(302) 631-3423
Sterling Diagnostic Imaging, Inc.
P. O. Box 6020
Route 896, Building 600
Glasgow Business Community
Newark, DE 19714-6020
Fax# (302) 631-3483 |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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)
Radiographic Intensifying Screen (892.1960) |
| Device Description: | The Sterling Diagnostic Imaging Direct
RadiographyTM device is used to directly capture
and convert conventional projection X-ray images
to digital images. A sub-sampled image can be
displayed on a preview monitor for viewing. The
diagnostic image can be transmitted through a
digital network for diagnostic viewing and printing.
The device provides digital image capture for
conventional radiographic examinations (excluding
fluoroscopic, angiographic, and mammographic
applications). The Direct RadiographyTM device
differs from traditional X-ray systems in that instead
of exposing a film for subsequent wet chemical
processing to create a hardcopy image, a device
called a digital array is used to capture the image in
electronic form. The digital data are then used to
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 (301) 594-4613. Additionally, for question and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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
(302) 631-3423
Sterling Diagnostic Imaging, Inc.
P. O. Box 6020
Route 896, Building 600
Glasgow Business Community
Newark, DE 19714-6020
Fax# (302) 631-3483 |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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)
Radiographic Intensifying Screen (892.1960) |
| Device Description: | The Sterling Diagnostic Imaging Direct
RadiographyTM device is used to directly capture
and convert conventional projection X-ray images
to digital images. A sub-sampled image can be
displayed on a preview monitor for viewing. The
diagnostic image can be transmitted through a
digital network for diagnostic viewing and printing.
The device provides digital image capture for
conventional radiographic examinations (excluding
fluoroscopic, angiographic, and mammographic
applications). The Direct RadiographyTM device
differs from traditional X-ray systems in that instead
of exposing a film for subsequent wet chemical
processing to create a hardcopy image, a device
called a digital array is used to capture the image in
electronic form. The digital data are then used to
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 (301) 594-4613. Additionally, for question and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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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