TELESIS DIGITAL INFRARED THERMAL IMAGE SYSTEM, SPECTRUM 9000MB

K020783 · Telesis Technologies, Inc. · LHQ · Jun 7, 2002 · Obstetrics/Gynecology

Device Facts

• Record ID: K020783
• Device Name: TELESIS DIGITAL INFRARED THERMAL IMAGE SYSTEM, SPECTRUM 9000MB
• Applicant: Telesis Technologies, Inc.
• Product Code: LHQ · Obstetrics/Gynecology
• Decision Date: Jun 7, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.2980
• Device Class: Class 1

Intended Use

The device is intended for adjunctive diagnostic screening for detection of breast cancer or other uses.

Device Story

Telesis Digital Infrared Thermal Image System (Spectrum 9000MB) is a telethermographic system. Device captures infrared thermal images of patient anatomy. System processes thermal data to produce visual thermal maps. Used by clinicians as an adjunctive diagnostic screening tool for breast cancer detection. Output allows healthcare providers to visualize temperature variations, aiding in clinical assessment. Intended for prescription use.

Technological Characteristics

Telethermographic system; digital infrared thermal imaging; Class I device; Product Code LHQ.

Indications for Use

Indicated for adjunctive diagnostic screening for detection of breast cancer or other uses.

Regulatory Classification

Identification

A telethermographic system for adjunctive diagnostic screening for detection of breast cancer or other uses is an electrically powered device with a detector that is intended to measure, without touching the patient's skin, the self-emanating infrared radiation that reveals the temperature variations of the surface of the body. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Submission Summary (Full Text)

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## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 7 2002

Mr. Ke-Min Jen Official Correspondent Telesis Technologies, Inc. 14F-3 & -4, No. 81, Sec. 1 Hsin-Tai-Wu Rd., His-Chih City, Taipei Hsien 221, TAIWAN, ROC

Re: K020783

Trade/Device Name: Telesis Digital Infrared Thermal Image System, Spectrum 9000MB Regulation Number: 21 CFR 884.2980 Regulation Name: Telethermographic system Regulatory Class: I Product Code: 90 LHQ Dated: February 25, 2002 Received: March 11, 2002

Dear Mr. Jen:

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 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 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), please . contact the Office of Compliance 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 your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International 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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## Telesis Technologies Incorporated

14F-3 & -4, No. 81, Sec. 1, Hsin-Tai-Wu Rd., His-Chih City, Taipei Hsien, 221, Taiwan, ROC TEL: [phone] FAX: [phone] E-MAIL: peter [e-mail]

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## 510 (K) NUMBER ( IF KNOW ):_ DEVICE NAME: TELESIS Digital Infrared Thermal Image System : Spectrum 9000MB INDICATIONS FOR USE:

The device is intended for adjunctive diagnostic screening for detection of breast cancer or other uses.

( PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE )

Concurrence of CDRH, office of Device Evaluation (ODE )

| Prescription Use | ✓ | OR | Over-The-Counter-Use |
|----------------------|---|----|--------------------------|
| (Per 21 CFR 801.109) | | | (Optional Format 1-2-96) |

| (Division Sign-Off) | |
|--------------------------------------|---------|
| Division of Reproductive, Abdominal, | |
| and Radiological Devices | |
| 510(k) Number | K020783 |

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