(407 days)
KO03130, K971956
Not Found
No
The document describes a standard thermography system with an infrared sensor and software for analysis and display. There is no mention of AI, ML, or related concepts, and the description of the technology aligns with traditional thermography.
No.
The device is described as a diagnostic tool ("adjunct to other clinical diagnostic procedures in the screening and diagnosis of abnormalities") and measures thermal patterns, rather than providing treatment.
Yes.
The "Intended Use / Indications for Use" section explicitly states it is "intended for use as an adjunct to other clinical diagnostic procedures in the screening and diagnosis of abnormalities."
No
The device description explicitly states that the system includes an "infrared sensor for measuring temperatures" which is a hardware component. The software is used for analysis and display, but it is not the sole component of the medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The EMD Thermography System measures and records thermal patterns generated by the human body externally using an infrared sensor placed in contact with the skin. It does not analyze samples taken from the body.
- Intended Use: The intended use describes the device as an adjunct to other clinical diagnostic procedures for screening and diagnosis of abnormalities. While it aids in diagnosis, it does so by measuring external physical properties (temperature) rather than analyzing biological samples.
Therefore, the EMD Thermography System falls under the category of a medical device but not specifically an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The EMD Thermography System is an infrared spectrum thermography system used to measure, record and view thermal patterns generated by the human body. It is intended for use as an adjunct to other clinical diagnostic procedures in the screening and diagnosis of abnormalities where a physician chooses to use thermography.
Product codes
LHQ, IYM
Device Description
The EMD Thermography System is an infrared frequency thermography system, designed to provide non-invasive temperature measurements of sites on the human body. The device includes an infrared sensor for measuring temperatures at specific areas on the skin surface. This sensor are placed in contact with the skin to perform measurements. A personal computer and software is for analysis of the temperature measurements and display of the temperature distributions.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Infrared thermography
Anatomical Site
human body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician
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)
I efromation submitted in this promarket notification for the EMD Thermography System includes results of testing for electrical safety, EMI/EMC, temperature measurement accuracy and results of clinical testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
KO03130, K971956
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 884.2980 Telethermographic system.
(a)
Telethermographic system intended for adjunctive diagnostic screening for detection of breast cancer or other uses —(1)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.(2)
Classification. Class I (general controls).(b)
Telethermographic system intended for use alone in diagnostic screening for detection of breast cancer or other uses —(1)Identification. A telethermographic system for use as the sole diagnostic screening tool 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.(2)
Classification. Class III.(3)
Date PMA or notice of completion of a PDP is required. As of the enactment date of the amendments, May 28, 1976, an approval under section 515 of the act is required before the device described in paragraph (b)(1) may be commercially distributed. See § 884.3.
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Image /page/0/Picture/1 description: The image shows the logo for EM Diagnostics Breastscan Technologies. The logo features a stick figure with outstretched arms and legs on the left. To the right of the figure is the text "EM Diagnostics" in a serif font, and below that is the text "BREASTSCAN TECHNOLOGIES" in a smaller, sans-serif font.
MAP 16 %0
510(k) Summary EM Diagnostics, Inc., EMD Thermography System, Model RTM-02-RES
Date Prepared: 20 February 2006
| Sponsor | Consultant | |
|---|---|---|
| Mr. Orest Lozynsky | Mr. Richard Keen | |
| EM Diagnostics, Inc. | Compliance Consultants | |
| 111 Center St., Suite 1200 | 1151 Hope Street | |
| Little Rock, AR 72201 | Stamford, CT 06907-1659 | |
| 501-907-7744 F 907 7745 | 203 329 2700 F 203 329 2345 | |
| orest@emdlr.com | rkeen@fda-complianceconsultants.com | |
| Device Name | Predicate Devices | |
| Proprietary Name: | ||
| EMD thermography system, Model RTM-01- | ||
| RES | KO03130 | |
| Regutherrn 952 | ||
| Common Name | ||
| Thermography System | K971956, CRT 2000 | |
| Thermographic System | ||
| Wemer Eidam. | ||
| Medizin-Technologie GmbH | ||
| Class I device | Regulation Number | Product Code |
| Telethermographic systems | 21 CFR 884.2980 | LHQ |
| liquid crystal thermographic systems | 21 CFR 884.2982 | IYM |
Obstetrical and Gynecological DevicePanel
Device Description
The EMD Thermography System is an infrared frequency thermography system, designed to provide non-invasive temperature measurements of sites on the human body. The device includes an infrared sensor for measuring temperatures at specific areas on the skin surface. This sensor are placed in contact with the skin to perform measurements. A personal computer and software is for analysis of the temperature measurements and display of the temperature distributions.
Intended Use
The EMD Thermography System is an infrared spectrum thermography system used to measure, record and view thermal patterns generated by the human body. It is intended for use as an adjunct to other clinical diagnostic procedures in the screening and diagnosis of abnormalities where a physician chooses to use thermography.
Di zuosni dri. 111 Center Street, Suite 1200 Little Rock. AR 72201 Tcl: 501.907.7744 Fax: 801.907.7745
Image /page/0/Picture/12 description: The image contains a handwritten number, "293". The number is written in a simple, slightly rounded style. The digits are clearly separated and legible, with the "2" and "9" being slightly taller than the "3".
1
Image /page/1/Picture/0 description: The image shows the logo for EM Diagnostics Breastscan Technologies. The logo features a stylized human figure on the left, followed by the text "EM Diagnostics" in a bold, sans-serif font. Below "Diagnostics" is the text "BREASTSCAN TECHNOLOGIES" in a smaller, sans-serif font.
Technological Characteristics And Substantial Equivalence
The EMD Thermography System is substantially equivalent to predicate direct contact the mography systems. The EMD Thermography System and the predicate devices have fundamentally the same indications for use. All of these devices are designed to be used to measure temperature.
Performance Testing
I efromation submitted in this promarket notification for the EMD Thermography System includes results of testing for electrical safety, EMI/EMC, temperature measurement accuracy and results of clinical testing.
Qe
20 February 2006
Mr. Orest Lozynsky
Date
E di Diagnogrics Inc. 111 Center Street, Suite 1200 Little Rock, AR 72201 Tel: 501.907.7744 Fax: 501.907.7745
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized image of an eagle or bird-like figure, with its head facing to the right and its wings forming a flowing, abstract shape.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 9 - 2008
EM Diagnostics, Inc. % Mr. James R. Veal Vice President, Strategic and Technical Assistance Medical Device Consultant 49 Plain Street NORTH ATTLEBORO MA 02760
Re: K050239
Trade/Device Name: EMD Thermography System, Model RTM-02-RES Regulation Number: 21 CFR 884.2980 Regulation Name: Telethermographic system Regulatory Class: I Product Code: LHQ Dated: February 20, 2006 Received: February 22, 2006
Dear Mr. Veal:
This letter corrects our substantially equivalent letter of March 16, 2006.
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 (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
3
CFR Part 807): labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act): 21 CFR 1000-1050.
This letter will allow you to continue marketing your device as described in your Section 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 (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
forni M. Whay
Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
4
Indications for Use
510(k) Number (if known): _K050239
Device Name: EMD-Thermography System, Model-RTM-02-RES
Indications for Use:
/
The EMD Thermography System, Model RTM-02-RES is an infrared spectrum thermography system used to measure, record and view thermal patterns generated by the human body. It is intended for use as an adjunct to other clinical diagnostic procedures in the screening and diagnosis of abnormalities where a physician chooses to use thermography.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel A. Segner
(Division Sign-Off) Division of Reproductive, Abdomina and Radiological Devices 510(k) Number
304