(310 days)
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Not Found
No
The summary mentions "image processor" and "image enhancement" but does not explicitly mention AI, ML, or related terms like deep learning or neural networks. The description of components is standard for digital imaging systems.
No
Explanation: The device is a digital imaging system designed for general radiography and fluoroscopy procedures, which are diagnostic rather than therapeutic.
Yes
The "Intended Use / Indications for Use" states that the system enables the operator to "bring out diagnostic details" in images, implying its use in diagnosis.
No
The device description explicitly lists hardware components (CCD camera, monitors, image processor) as major system components.
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 description clearly states that the Swissray Telleray AG Digital Add-on Bucky system is a digital imaging system for Digital Photofluorography and general Radiography and fluoroscopy procedures performed on a patient. This involves imaging the inside of the body using X-rays, not analyzing samples taken from the body.
- Intended Use: The intended use is to replace conventional film techniques for radiography and fluoroscopy, and to perform general radiography on patients in various positions. This is consistent with medical imaging, not in vitro testing.
Therefore, the device falls under the category of medical imaging equipment, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Swissray Telleray AG Digital Add-on Bucky system is a high resolution, digital imaging system designed for Digital Photofluorography. It is intended to replace conventional film techniques or dedicated applications where general Radiography and fluoroscopy procedures are performed. The Digital Add-on Bucky is intended for applying general radiography on a patient in a supine, seated, or standing position including tomography examinations.
Product codes
90 KPR
Device Description
The Digital Add-on Bucky system allows the operator to view and enhance the images may be viewed and enhanced enabling the operator to bring out diagnostic details difficult or impossible to see using conventional imaging techniques.
The Add-on Bucky system enables the operator to hardcopy images with a laser printer. The major system components include: a CCD camera, monitors and an image processor.
Mentions image processing
Yes
Mentions AI, DNN, or ML
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Input Imaging Modality
Digital Photofluorography, general Radiography, fluoroscopy
Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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 the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the logo is an abstract symbol that resembles a stylized human figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 | 1997
Michael Baker CEO Swissary Information Solutions 5775 Soundview Drive, Suite 103A Gig Harbor, Washington 98335
Re:
: K9
K970136 Swissary Telleray AG Digital Add-on Bucky System Dated: November 4, 1997 Received: November 5, 1997 Regulatory class: II 21 CFR 892.1680/Procode: 90 KPR
Dear Mr. Baker:
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, 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 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
Wiliau 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
Enclosure
1
Page 1 of 1
510(k) Number (if known):
Device Name: Patriot
Indication For Use:
The Swissray Telleray AG Digital Add-on Bucky system is a high resolution, digital imaging system designed for Digital Photofluorography. It is intended to replace conventional film techniques or dedicated applications where general Radiography and fluoroscopy procedures are performed. The Digital Add-on Bucky is intended for applying general radiography on a patient in a supine, seated, or standing position including tomography examinations.
The Digital Add-on Bucky system allows the operator to view and enhance the images may be viewed and enhanced enabling the operator to bring out diagnostic details difficult or impossible to see using conventional imaging techniques.
The Add-on Bucky system enables the operator to hardcopy images with a laser printer. The major system components include: a CCD camera, monitors and an image processor.
(PLEASE DO NOT WRITE BELLOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (DOE)
Prescription Use
OR
Over-The Counter Use
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
David L. Ryerson
(Division Sign. Off.)
(Division Sign-Off) Division of Reproductive, Abdominal, El and Radiological Dev 510(k) Number