(87 days)
Not Found
Not Found
No
The provided text does not contain any mention of AI, ML, deep learning, or related concepts, nor does it describe functionalities typically associated with AI/ML in medical imaging (like automated analysis, detection, or prediction).
No
The LC positioner is described as an accessory to a fluoroscopic unit for imaging, indicating a diagnostic rather than therapeutic purpose.
No
The device is described as an "accessory to a fluoroscopic unit for imaging" the cardiovascular system. Its purpose is to position, not to diagnose. Diagnostic devices perform the imaging or analyze the images to make a diagnosis.
No
The summary describes a "positioner" used as an accessory to a fluoroscopic unit. This strongly implies a physical device used to position something, not a software-only product. The lack of any mention of software, algorithms, or data processing further supports this conclusion.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "as an accessory to a fluoroscopic unit for imaging the cardiovascular system." This describes a device used in vivo (within a living organism) for imaging, not a device used in vitro (outside the body) to examine specimens like blood, tissue, or urine.
- Device Description: While "Not Found," the intended use clearly points to an imaging accessory.
- Mentions image processing, AI, DNN, or ML: These are often associated with IVD devices that analyze images of specimens, but their absence here doesn't definitively rule out IVD. However, combined with the intended use, it further supports the conclusion.
- Input Imaging Modality: Fluoroscopic is an in vivo imaging modality.
- Anatomical Site: Cardiovascular system is an in vivo anatomical site.
IVD devices are specifically designed to examine specimens obtained from the human body to provide information for diagnosis, monitoring, or screening. This device's function is to position for in vivo imaging.
N/A
Intended Use / Indications for Use
The LC positioner is to be used as an accessory to a fluoroscopic unit for imaging the cardiovascular system.
Product codes
90 JAA
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
fluoroscopic
Anatomical Site
cardiovascular system
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): 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.
Not Found
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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. 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). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic 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. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression 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 caduceus symbol, which is a staff with two snakes coiled around it, representing medicine and healing. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Jul 1 6 1998
Director, Regulatory Affairs/Quality Assurance
K981414 LC Positioner (Fluoro C-Arm) March 31, 1998 Dated: Received: April 20, 1998 Regulatory class: II 21 CFR 892.1650/Procode: 90 JAA
Dear Ms. Emrich:
Samuella D. Emrich
Fischer Imaging Corp.
12300 North Grant Street
Denver, CO 80241-3120
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 probibitions against misbranding and adulteration.
Re:
If your device is classified (see above) into either class II (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 (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 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 Internet address "http://www.fda.gov/cdrh/dsmaldsmam.html".
Sincerely yours,
Lillian Yin, 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
ATTACHMENT A
Initial 510(k)
K98/4/4
Device Name: Indications for Use: LC Positioner The LC positioner is to be used as an accessory to a fluoroscopic unit for imaging the cardiovascular system.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _
or Over-the-Counter Use ______________________________________________________________________________________________________________________________________________________
(per 21 CFR 801.109)
David C. Began
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological De 510(k) Number