(45 days)
IA-16LM
IA-16LM
No
There is no mention of AI, ML, image processing, or any related concepts in the provided text. The description focuses on the intended use, users, and comparison to a predicate device.
No.
The document indicates its use in fluoroscopy and fluorography by physicians and X-ray technologists, which are diagnostic imaging procedures, not therapeutic interventions.
No
This device is used for fluoroscopy and fluorography, which are imaging techniques. It does not state that it analyzes or interprets the images to provide a diagnosis.
Unknown
The provided 510(k) summary lacks a "Device Description" section, which is crucial for determining if the device is software-only. The information available focuses on intended use, users, and predicate devices, but does not describe the physical or software components of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "fluoroscopy and fluorography," which are imaging techniques used to visualize internal structures of the body in real-time or with still images. This is a diagnostic imaging modality, not a test performed on samples taken from the body (like blood, urine, or tissue).
- Device Description (Not Found): While the description is missing, the intended use strongly points away from an IVD.
- Input Imaging Modality: "fluoroscopy and fluorography" are imaging modalities, not methods for analyzing biological samples.
- No mention of analyzing biological samples: The provided text does not mention any analysis of blood, urine, tissue, or any other biological material.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's intended use clearly falls under medical imaging.
N/A
Intended Use / Indications for Use
/ This device is intended to be used in the fluoroscopy and fluorography. / This device is operated and used by Physicians and X-ray technologist. / The object of this device is total patient population. As mentioned at "Intended Use" in this notification, the intended use of the IA-16L/HS is the same as that of predicate device IA-16LM. Consequently, the indications for use of the IA-16L/HS are also the same as that of the IA-16LM and there are no additional indications.
Product codes
90 JAA
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
total patient population
Intended User / Care Setting
Physicians and X-ray technologist.
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)
IA-16LM
Reference Device(s)
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other, with wavy lines below them.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 7 2004
Shimadzu Corporation % Mr. Michael Fishback Director, National Service and Regulatory Affairs Shimadzu Medical Systems 20101 South Vermont Avenue TORRANCE CA 90502-1328 Re: K040870 Trade/Device Name: Shimadzu Image Amplifier IA-16L/HS Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: 90 JAA Dated: March 24, 2004 Received: April 28, 2004
Dear Mr. Fishback:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
This letter will allow you to begin marketing your device as described in your Section 510(k) I ms lotter will and in your as FDA finding of substantial equivalence of your device to a legally promaticated predicated." " " 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), please 11 you assn office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Bugden
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page1_of1
510(K) Number (if known): Unknown K040870
IA-16L/HS Device Name
Indications For Use:
/ This device is intended to be used in the fluoroscopy and fluorography.
/ This device is operated and used by Physicians and X-ray technologist.
/ The object of this device is total patient population.
As mentioned at "Intended Use" in this notification, the intended use of the IA-16L/HS is the same as that of predicate device IA-16LM.
Consequently, the indications for use of the IA-16L/HS are also the same as that of the IA-16LM and there are no additional indications.
(Please Do Not WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per21CFR801.109) OR
Over-The-Counter Use
Lijndrik Leemans
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K040870