TOSHIBA RTP9211J-G11, J-ADVANCED IMAGE INTENSIFIER (I.I.)

K993038 · Toshiba America Medical Systems, In.C · JAA · Oct 7, 1999 · Radiology

Device Facts

• Record ID: K993038
• Device Name: TOSHIBA RTP9211J-G11, J-ADVANCED IMAGE INTENSIFIER (I.I.)
• Applicant: Toshiba America Medical Systems, In.C
• Product Code: JAA · Radiology
• Decision Date: Oct 7, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1650
• Device Class: Class 2

Indications for Use

The Toshiba J-Advanced I.I. is designed to capture x-ray images on a phosphor, and convert the xray pattern into a corresponding light image of a higher energy density. The intended use of this product is commensurate with other products currently in the marketplace.

Device Story

The J-Advanced I.I. (Image Intensifier) is a component for fluoroscopic X-ray systems. It functions by capturing incident X-ray patterns on a phosphor screen and converting them into a light image of higher energy density. This device is used in clinical settings as part of a larger X-ray imaging system operated by trained medical professionals. It serves to enhance the visibility of X-ray images for diagnostic purposes, aiding clinicians in clinical decision-making during fluoroscopic procedures. The device represents a technological evolution of previous intensifier models, focusing on improved resolution and contrast specifications to benefit patient imaging outcomes.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological comparison and performance specifications (resolution and contrast) relative to the predicate device.

Technological Characteristics

X-ray image intensifier; phosphor-based X-ray to light conversion; improved resolution and contrast compared to predicate. Complies with 21 CFR Subchapter J (Federal Diagnostic X-ray Equipment Standard) and IEC-60601 safety standards.

Indications for Use

Indicated for capturing x-ray images on a phosphor and converting the x-ray pattern into a light image of higher energy density for diagnostic fluoroscopic imaging.

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

• Toshiba 6' I.I. System (K771298)

Submission Summary (Full Text)

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7 1999 OCT

# 510(k) Summary

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| Date: | 9 September 1999 |
|---------------------------------------|----------------------------------------------------------------------------------------------|
| Submitter's Name: | Toshiba America Medical Systems, Inc. |
| Submitter's Address: | P.O. Box 2068, 2441 Michelle Drive,<br>Tustin, CA 92781-2068 |
| Submitter's Contact: | Diana Thorson, Regulatory Affairs Specialist, [phone] |
| Establishment Registration<br>Number: | 2020563 |
| Device Proprietary Name: | Toshiba RTP9211J-G11, J-Advanced Image Intensifier (I.I.) |
| Common Name: | System, X-Ray, Fluoroscopic, Image Intensified<br>[Fed. Reg. No. 892.1650, Pro. Code: 90JAA] |
| Regulatory Class: | II (per 21 CFR 892.1650) |
| Performance Standard: | 21 CFR Subchapter J,<br>Federal Diagnostic X-ray Equipment Standard |
| Predicate Device(s): | Toshiba 6' I.I. System [K771298] |
| Reason For Submission | Modification of cleared device |

## Description of this Device:

The J-Advanced I.I., Model RTP9211J-G11 is a modification to a previously cleared device, 6' I.I. system [K771298].

## Summary of Intended Uses:

The Toshiba J-Advanced I.I. is designed to capture x-ray images on a phosphor, and convert the xray pattern into a corresponding light image of a higher energy density. The intended use of this product is commensurate with other products currently in the marketplace.

# Technological Characteristics:

This device employs the same technological characteristics as the predicate device. The changes to the device are a result of continuing technological development towards the goals of increasing efficiency and reducing cost. A comparison of the performance characteristics of the new intensifier to the previous models shows nominally improved resolution and contrast specifications. There are no new claims of effectiveness and no new intended uses offered with this new intensifier.

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### Safety and Effectiveness Concerns:

This device is designed and manufactured under the Quality System Regulations as outlined in 21 CFR § 820. All requirements of the Federal Diagnostic Equipment Standard, as outlined in 21 CFR § 1020.30 and 1020.33, that apply to this device, will be met and reported via a supplement to the initial report for the predicate device. Additionally this system is in conformance with the applicable parts of the IEC-60601 - Medical Device Safety standards.

### Substantial Equivalence:

Based upon the above considerations TAMS believes that this device, J-Advanced I.I., Model RTP9211J-G11, is substantially equivalent to the predicate, Toshiba 6" I.I. System.

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Public Health Service

Rockville MD 20850

Food and Drug Administration 9200 Corporate Boulevard

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

OCT 7 1999

Ms. Diana Thorson Regulatory Affairs Specialist Toshiba America Medical Systems, Inc. 2441 Michelle Drive, P.O. Box 2068 Tustin, CA 92781-2068

Dear Ms. Thorson:

h

Re:

K993038 J-Advanced Image Intensifier Model RTP9211J-G11 Dated: September 9, 1999 Received: September 10, 1999 Product Code: 90 JAA Requiatory Class: II (TWO) 21 CFR 892.1650

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 legally marketed predicate devices marketed in interstate commerce pror to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been redassified 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 equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) 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 [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 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 [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive. Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): _________________________________________________________________________________________________________________________________________________

Device Name: J-Advanced I.I., RTP9211J-G11

Indications for Use:

The Toshiba J-Advanced I.I. is designed to capture x-ray images on a phosphor, and convert the x-ray The Fosmba 5-AG ranced in 15 b been and a higher energy density.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices

| 510(k) Number | K993038 |
|---------------|---------|
|---------------|---------|

| Prescription Use | <div style="text-align:center;">OR</div> | Over-The-Counter Use |
|----------------------|------------------------------------------|----------------------|
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) | |