(10 days)
Not Found
Not Found
No
The summary describes a manual collimator, an accessory for controlling the x-ray beam, with no mention of AI, ML, image processing, or data sets typically associated with AI/ML development and validation.
No
The device is described as an accessory to control the x-ray beam for use on diagnostic imaging equipment, not for therapy or treatment.
No
The device is described as an accessory to control the x-ray beam for use on diagnostic imaging equipment, not a diagnostic device itself.
No
The device description explicitly states "AXT 150M Manual Collimator," which is a hardware component used to control the x-ray beam. The summary does not indicate that the device is solely software.
Based on the provided information, the AXT 150M Manual Collimator is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is an "accessory to control the x-ray beam for use on a diagnostic Imaging equipment." This describes a device used in vivo (on a living patient) for imaging, not in vitro (outside the body) for testing biological samples.
- Device Description: The description "Manual Collimator" aligns with a component of an X-ray imaging system, not a device for analyzing biological samples.
- Input Imaging Modality: The input modality is "X-ray," which is used for imaging the body, not for analyzing biological samples.
- Anatomical Site: While not specified, the use with X-ray imaging equipment implies use on a patient's body.
- Intended User: The intended users are "licensed MD or RT," which are medical professionals involved in patient care and imaging, not typically those performing in vitro diagnostic tests.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The AXT 150M does not fit this description. It is a component of an X-ray system used for diagnostic imaging of the body.
N/A
Intended Use / Indications for Use
The AXT 150M and/or variations is intended to be used by or under the authority of a licensed MD or RT. The AXT 150M and/or its variations is accessories to control the x-ray beam for use on a diagnostic imaging equipment. The intended market will consist of OEM's (Original Equipment Manufacturers), as a designed to be adapted to various x-ray systems.
Product codes
90 IZX
Device Description
AXT 150M (Manual Collimator)
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
licensed MD or RT. The intended market will consist of OEM's (Original Equipment Manufacturers).
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
§ 892.1610 Diagnostic x-ray beam-limiting device.
(a)
Identification. A diagnostic x-ray beam-limiting device is a device such as a collimator, a cone, or an aperture intended to restrict the dimensions of a diagnostic x-ray field by limiting the size of the primary x-ray beam.(b)
Classification. Class II (special controls). The device 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 Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 21 1997
Howard C. Thomas . President Applied X-Ray Technologies, Inc. 2727 West 92nd Avenue, Suite 10 Denver, CO 80221
Re:
K972966 AXT 150M (Manual Collimator) Dated: August 8, 1997 Received: August 11, 1997 Regulatory class: II 21 CFR 892.1610/Procode: 90 IZX
Dear Mr. Thomas:
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 yitro 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 Internet address http://www.fda gov/cdrh/dsmamain.html".
Sincerely yours.
h7liau y
William Yiu, Ph.D.
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
510(k) Number (if known):_K972966
Device Name: AXT150M Manual Collimator
Indications For Use:
The AXT 150M and/or variations is intended to be used by or unders The AXT 150M and/or its the authority of a licensed MD or RT. che authority or a recontrol the x-ray beam for use on a diagvariations is accures to con. The intended market will consist of nostic Imaging equipment. The The Inconded Marios Mebusiders Original Equipment Handraccures (ULN), as a signed to be adapted to various x-ray systems.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel G. Stetson
(Division Sign-Off) Division of Reproductive, Abdominal, EN and Radiological D 510(k) Number
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)