(118 days)
Empty
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and provides no other information suggesting the use of these technologies.
No
The device is described as being for "GENERAL RADIOGRAPHIC MEDICAL X-RAY PROCEDURES," which are diagnostic imaging procedures, not therapeutic ones.
No
The device is described as performing "GENERAL RADIOGRAPHIC MEDICAL X-RAY PROCEDURES," which refers to image acquisition, not the interpretation or diagnosis of medical conditions.
No
The summary describes an X-ray device ("STERNE ACU-RAY HF") used for general radiographic procedures, which is a hardware device. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "GENERAL RADIOGRAPHIC MEDICAL X-RAY PROCEDURES". This describes a procedure performed on a patient using an X-ray machine, not a test performed on a sample (like blood, urine, or tissue) outside the body.
- Device Description: "STERNE ACU-RAY HF" sounds like an X-ray machine or a component of one.
- Input Imaging Modality: "X-Ray" is an imaging modality used on a patient, not a method for analyzing a biological sample.
IVD devices are used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening. This device's description and intended use clearly indicate it's for generating images of the inside of a patient's body, which is not the function of an IVD.
N/A
Intended Use / Indications for Use
GENERAL RADIOGRAPHIC MEDICAL X-RAY PROCEDURES
Product codes
90 IZL
Device Description
Not Found
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
§ 892.1720 Mobile x-ray system.
(a)
Identification. A mobile x-ray system is a transportable device system intended to be used to generate and control x-ray for diagnostic procedures. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is a stylized image of three human figures, representing health, hope, and service. The figures are depicted in a flowing, abstract style.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT - 8 1997
Brent Nelson Sterne Equipment Co., LTD. 7 Research Rd. Brampton, Ontario L6W 1P4 Canada
Re:
K972204 ACU-Ray HF Series Portable X-Ray Unit Dated: June 23, 1997 Received: September 17, 1997 Regulatory class: II 21 CFR 892.1720/Procode: 90 IZL
Dear Mr. Nelson:
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 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.
W.T.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
Enclosure
1
Page__________________________________________________________________________________________________________________________________________________________________________ 이
510 (k) Number (if known): N/A
Device Name: STERNE ACU-RAY HF
Indications for Use: GENERAL RADIOGRAPHIC MEDICAL X-RAY PROCEDURES
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (per 21 CFR 801.109)
Over The Counter Use_________
(Optional Format 1-2-96)
David A. Heyman
(Division Sign-Off) (Division of Reproductive, Abdominal, ENT, and Radiological Dev 510(k) Number