(80 days)
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description and intended use are consistent with traditional image intensifiers for fluoroscopy.
No
The device is described as an image amplifier used for fluoroscopy and fluorography, which are diagnostic (imaging) procedures, not therapeutic ones.
No
The device is an image amplifier used in fluoroscopy and fluorography. Its purpose is to enhance images, which is a part of the imaging process, but it does not inherently diagnose or provide diagnostic conclusions itself. Diagnostic devices typically analyze data or images to identify diseases or conditions.
No
The device description explicitly lists "Shimadzu Image Amplifiers" with model numbers, which are hardware components used in fluoroscopy and fluorography. The summary does not indicate that the device is solely software controlling or processing data from these amplifiers.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for use in fluoroscopy and fluorography. These are medical imaging techniques that use X-rays to visualize internal structures of the body in real-time.
- Device Description: The device is described as "Shimadzu Image Amplifiers." Image amplifiers are components of X-ray systems used to enhance the brightness of the X-ray image.
- Input Imaging Modality: The input modalities are Fluoroscopy and Fluorography.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) outside of the body to provide information for diagnosis, monitoring, or screening. IVDs typically involve analyzing biological samples.
The information provided strongly indicates this is a medical imaging device used for diagnostic purposes in vivo (within the living body), not an in vitro diagnostic device.
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 populations.
As mentioned at "Intended Use" in this notification, the intended use of the IA-16LM is the same as that of predicate device IA-16VMA12 in KV-RF (K984111).
The Indications For Use of the IA-16LM are also the same as that of the IA-16VMA12 in KV-RF (K984111) 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 populations
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)
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.
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Image /page/0/Picture/1 description: The image shows a logo for the Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH &" written along the left side and "HUMAN SERVICES" written along the right side. Inside the circle is a stylized image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 8 2001
Shimadzu Corp. % Mr. Michael Fishback Director, National Service And Regulatory Affairs Shimadzu Medical Systems 20101 South Vermont Ave. TORRANCE CA 90502-1328 Re: K012424
K012424
Trade/Device Name: Shimadzu Image Amplifiers: IA-16LM IA-16LT, IA-16LD, IA-12LD/HG, IA-12LT/F Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: 90 JAA Dated: July 17, 2001 Received: July 30, 2001
Dear Mr. Fishback:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your becaon 31 ttps, pe device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for the stated in the cablosure) to regionent date of the Medical Device Amendments, or to comments phor to May 20, 1978, in accordance with the provisions of the Federal Food, Drug, devices that have been resulted mequire approval of a premarket approval application (PMA). and Costine Act (Act) that to not required to the general controls provisions of the Act. The r ou may, dicitions provisions of the Act include requirements for annual registration, listing of general controls provisions of wactice, 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 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.
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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 nouncedion. The PDA imania of casomantar vour 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 II you desire specific advice at one of the following numbers, based on the regulation number at the top of this 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" (21 CFR Part 807.97). Other general information on by receined to promative act may be obtained from the Division of Small Manufacturers, your rosponsional 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. Brogdon
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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Notification Submission, 510(K) SECTION XI:
Page 14 IA-16LM INDICATION FOR USE STATEMENT
Page1_of1
Unknown KO12423 510(K) Number(if known) : ..
Device Name
IA-16LM
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 populations.
As mentioned at "Intended Use" in this notification, the intended use of the As mentionou at "interesary as that of predicate device IA-16VMA12 in KV-RF (K984111).
- ToLM is the Same as that of posses of the IA-16LM are also the same as that of the IA-16VMA12 in KV-RF (K984111) and there are no additional indications.
(Please DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER NEEDED ) PAGE IF
Concurrence of CDRH, Office of Device Evaluation(ODE)
Prescription Use (Per21CFR801.109) OR
Over-The-Counter Use
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David G. Bergman