(145 days)
None
Not Found
No
The summary describes a solid-state x-ray acquisition device that replaces film cassettes. There is no mention of AI, ML, or advanced image processing beyond basic acquisition.
No.
The device is described as an x-ray acquisition device that replaces film cassettes, indicating it is used for diagnostic imaging rather than therapy.
No
The device is described as an "x-ray acquisition device" designed to replace film-cassettes, which means it captures x-ray images. It does not perform analysis or diagnosis based on the acquired images.
No
The device description explicitly states it is a "solid-state (electronic) x-ray acquisition device," indicating it is a hardware component designed to replace physical film cassettes.
Based on the provided information, the DX-480 Imager Unit is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is an "x-ray acquisition device designed to replace film-cassettes used in conventional x-ray processes." This describes a device used for in vivo imaging (imaging within a living organism), not for testing samples in vitro (outside of a living organism).
- Device Description: The description reinforces its function as an x-ray acquisition device used in conjunction with positioning equipment for conventional x-ray processes.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests on these samples, or providing diagnostic information based on such tests.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The DX-480 Imager Unit's function is to capture x-ray images of the body itself.
N/A
Intended Use / Indications for Use
The DX-480 Imager Unit is a solid-state ( electronic ) x-ray acquisition device designed to replace film-cassettes used in conventional x-ray processes. The imager is designed to be mounted in a wide variety of positioning devices such as floating tables, swing-arm assemblies, and upright stands.
Product codes
90 KPR
Device Description
The DX-480 Imager Unit is a solid-state ( electronic ) x-ray acquisition device designed to replace film-cassettes used in conventional x-ray processes. The imager is designed to be mounted in a wide variety of positioning devices such as floating tables, swing-arm assemblies, and upright stands.
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)
Not Found
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/1 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 caduceus or a representation of human figures.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 20 1998
David Andres Official Correspondent Wuestec Medical, Inc. 421 Holcolmbe Ave. Mobile, AL 36606
Re:
DX-480, Add on Digital Imager Dated: May 27, 1998 Received: May 28, 1998 Regulatory class: II 21 CFR 892.1680/Procode: 90 KPR
Dear Mr. Andres:
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, 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 Current Good Manufacturing Practice requirements, 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 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 (301) 594-4613. Additionally, for questions on the promotion 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 finternet address "http://www.fda.gov/cdr/dsmaldsmamain.html".
Sincerely yours,
William Yip
Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
1
INDICATIONS FOR USE
K981880 510(k) Number:
DX-480 Device Name:
The DX-480 Imager Unit is a solid-state ( electronic ) x-ray acquisition device designed to replace film-cassettes used in conventional x-ray processes. The imager is designed to be mounted in a wide variety of positioning devices such as floating tables, swing-arm assemblies, and upright stands.
David A. Sayre
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devi 510(k) Number
Prescription Use
(Per 21 CFR 801.109)