(29 days)
Not Found
Not Found
No
The summary does not contain any mentions of AI, ML, or related concepts, nor does it describe features or performance metrics typically associated with AI/ML-powered devices.
No
The device is described as a "General Purpose Fluoroscope." Fluoroscopes are imaging devices used for diagnostic purposes, not for treating diseases or conditions.
No
The "Intended Use / Indications for Use" states "General Purpose Fluoroscope Applications". This indicates it is an imaging device used to visualize things, not to diagnose a condition based on the images.
Unknown
The provided 510(k) summary is incomplete and lacks a device description, making it impossible to determine if the device is software-only or includes hardware components.
Based on the information provided, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "General Purpose Fluoroscope Applications." Fluoroscopy is an imaging technique used to visualize internal structures of the body in real-time. This is an in vivo (within the living body) diagnostic method, not an in vitro (outside the living body) diagnostic method.
- Device Description: While not found, the intended use strongly suggests an imaging device used on a patient.
- Input Imaging Modality: "Fluoroscope" confirms it's an imaging device used on a patient.
IVD devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This description clearly points to a device used directly on a patient for imaging purposes.
N/A
Intended Use / Indications for Use
General Purpose Fluoroscope Applications
Product codes
90 IZX, 90 ITY, 90 IZO
Device Description
Monoblock Diagnostic X-Ray Tube Housing Assembly
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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
§ 892.1610 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 U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 6 1998
Raymond Manez Director, Q.A./ Regulatory Affairs DynaRad Corporation 19 Jefryn Blvd. West Deer Park, NY 11729
Re:
K981267 Facts Monoblock Diagnostic X-Ray Tube Housing Assembly Dated: April 2, 1998 Received: April 7, 1998 Regulatory class: II 21 CFR 892.1610/Procode: 90 IZX/90 ITY/90 IZO
Dear Mr. Manez:
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 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 equivalier determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) 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 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) 594-639. 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/dsmaldsmamain.html".
Sincerely yours,
Kilian Yin
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): K981267
Device Name: Monoblock
Indications For Use:
General Purpose Fluoroscope Applications
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Virgil A. Severson
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K981267
(Optional Format 3-10-98)
Prescription Use
(Per 21 CFR 801.109)
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