TRANSVIEW (TRANSMISSION SYSTEM),MODEL NDTR-701A

K982300 · Toshiba America Medical Systems, In.C · KPS · Sep 25, 1998 · Radiology

Device Facts

• Record ID: K982300
• Device Name: TRANSVIEW (TRANSMISSION SYSTEM),MODEL NDTR-701A
• Applicant: Toshiba America Medical Systems, In.C
• Product Code: KPS · Radiology
• Decision Date: Sep 25, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1200
• Device Class: Class 2

Intended Use

To detect or image the distribution of radionuclides in the body or organ, using the following technique(s). Tomographic imaging (SPECT) for non Positron emitter.

Device Story

TRANSVIEW (Model NDTR-701A) is an add-on transmission CT (TCT) system for Toshiba GCA-7200 gamma cameras. It utilizes an external uncollimated sheet line source and a parallel-hole collimator to acquire transmission data. The system generates anatomic frame attenuation maps; these maps are used to perform non-uniform attenuation correction and scatter correction on SPECT images. Operated by nuclear medicine technicians or physicians in clinical settings, the device enhances image quality by correcting for photon attenuation. The resulting corrected SPECT images assist clinicians in diagnostic interpretation by providing more accurate radionuclide distribution visualization, potentially improving diagnostic confidence.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological characteristics and the established nature of non-uniform attenuation correction in nuclear medicine.

Technological Characteristics

Transmission-based attenuation correction system for gamma cameras. Components include an external uncollimated sheet line source and a parallel-hole collimator. Operates by acquiring transmission CT data to generate attenuation maps. Performs non-uniform attenuation and scatter correction on SPECT images. Energy range for SPECT imaging is 50-400 keV.

Indications for Use

Indicated for patients requiring tomographic imaging (SPECT) for non-positron emitters to detect or image the distribution of radionuclides in the body or organ.

Regulatory Classification

Identification

An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.

Predicate Devices

• ADAC Vantage (K943596)
• Picker STEP 2000 Option (K960865)
• Siemens E CAM Profile (K963983)
• Elscint TransACT (K952674)

Submission Summary (Full Text)

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SEP 2 5 1998

## 510(k) Summary

K982300

| Date: | June 15, 1998 |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------|
| 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: | Donelle Krajewski, Regulatory Affairs Specialist,<br>[phone], Extension 4121 |
| Device Proprietary Name: | TRANSVIEW (Transmission System), Model NDTR-701A |
| Classification Name: | Emission Computed Tomography System |
| Common Name: | Gamma Camera Option<br>[Fed. Reg. No. 892.1200, Pro. Code: 90 KPS] |
| Predicate Devices: | ADAC Vantage (K943596), Picker STEP 2000 Option<br>(K960865), Siemens E CAM Profile (K963983), and<br>Elscint TransACT (K952674) |
| Reason for Submission | New option for existing product |

### Description of this Device:

The TRANSVIEW (Transmission system), model NDTR-701A is an option designed to be used with Toshiba's GCA-7200 gamma camera systems to acquire transmission CT data (TCT). When the external flood source of this system is combined with a parallel-hole collimator, this system can generate anatomic frame attenuation maps and perform attenuation corrections on SPECT images.

#### Summary of Intended Uses:

The purpose of this option is to provide non-uniform attenuation correction, simultaneously or sequentially, using a uncollimated sheet line source and a parallel-hole collimator. Toshiba America Medical Systems, Inc. believes that this device is safe and effective in that it offers no new intended uses that are not in use on existing marketed devices.

### Technological Characteristics:

This device employs the same technological characteristics as the predicate devices, differing only in the specifics of subassembly component composition and algorithms used. All systems employ the use of a transmission source to provide the attenuation map. This attenuation map is then used to perform attenuation corrections on SPECT images along with scatter correction. Non uniform attenuation correction using transmission systems is well understood and is documented in peer reviewed scientific publications.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Rockville MD 20850

Food and Drug Administration 9200 Corporate Boulevard

Image /page/1/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of a bird or abstract human figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.

SEP 2 5 1998

Donelle Kajewski Regulatory Affairs Specialist Toshiba America Medical Systems, Inc. 2441 Michelle Drive P.O. Box 2068 Tustin, CA 92781

Re:

K982300 TransView (Transmission System), Model NDTR-701A Dated: June 15, 1998 Received: July 1, 1998 Regulatory class: II 21 CFR 892.1200/Procode: 90 KPS

Dear Mr. Kajewski:

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, against. misbranding and adulteration.

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 (2) 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 predication 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 vite 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/dsmaldsmamain.html".

Sincerely yours,

Lillian Yin, Ph.D.

Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# RECEIV ¯

# APR 2 4 1998

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REGULATORY AFFAIR®

| 510(k) Number (if known): | and and and the results of the cases of the |
|---------------------------|---------------------------------------------|
|---------------------------|---------------------------------------------|

Device Name: JRAN'S UIEW WEW _________________________________________________________________________________________________________________________________________________

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### Nuclear Medicine Device

Indication For Use: To detect or image the distribution of radionuclides in the body or organ, using the following technique(s).

| | XES | ಗರ | Energy Range (keV) |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----|----|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 4<br>Planar imaging<br>A. | | X | |
| Whole body imaging<br>B. | | | |
| C.<br>Tomographic imaging (SPECT)<br>for non Positron emitter | × | | 50-400 |
| D.<br>Positron imaging by coincidence | | × | |
| Positron imaging without coincidence<br>E. | | | |
| F.<br>Other indication(s) in the device label,<br>but not included in above list | | | ース アニメーカー アイト アパート アイト アイト アイト アイト アイト アイト アイ |
| | | | |
| | | | ーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーー |
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| (Please do not write below this line - Continue on another page if needed) | | | |
| Concurrence of CDRH, Office of Device Evaluation (ODE) | | | |
| Prescription Use______________________________________________________________________________________________________________________________________________________________<br>OR<br>(Per 21 CFR 801.109)<br>(Division Sign-Off)<br>Division of Reproductive, Abdominal, ENT,<br>and Radiological Devices<br>510(k) Number . | | | Over-the-Counter Use__________________________________________________________________________________________________________________________________________________________<br>(Optional Format 1-2-96) |