SHIMADZU IMAGE AMPLIFIER MODEL # IA-16LM

K012424 · Shimadzu Corp. · JAA · Oct 18, 2001 · Radiology

Device Facts

• Record ID: K012424
• Device Name: SHIMADZU IMAGE AMPLIFIER MODEL # IA-16LM
• Applicant: Shimadzu Corp.
• Product Code: JAA · Radiology
• Decision Date: Oct 18, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1650
• Device Class: Class 2
• Attributes: Pediatric

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.

Device Story

Shimadzu Image Amplifiers (IA-16LM, IA-16LT, IA-16LD, IA-12LD/HG, IA-12LT/F) function as components within image-intensified fluoroscopic X-ray systems. These devices capture X-ray signals and convert them into visible light images for real-time visualization during diagnostic or interventional procedures. Operated by physicians and X-ray technologists in clinical settings, the amplifiers enhance the visibility of internal structures, aiding in clinical decision-making and procedural guidance. The devices serve as direct replacements for existing image intensifier technology, maintaining the same operational workflow and clinical utility as the predicate device.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Image-intensified fluoroscopic X-ray system components. These devices function as image intensifiers to convert X-ray radiation into visible light. They are designed for integration into existing fluoroscopy/fluorography systems. No specific materials, software algorithms, or connectivity features are detailed.

Indications for Use

Indicated for use in fluoroscopy and fluorography for all patient populations. Operated by physicians and X-ray technologists.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• IA-16VMA12 in KV-RF (K984111)

Submission Summary (Full Text)

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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 | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

3

David G. Bergman