(16 days)
N/A
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on image collection and conversion, not analysis using AI/ML.
No
The device is used for diagnosis, not treatment. It collects dental x-ray photos to convert them into electronic data for diagnosis, not to provide therapy.
Yes
Explanation: The "Intended Use / Indications for Use" states that the device collects dental x-ray photos to be used "for the diagnosis of the teeth, jaw and oral structures." The "Device Description" also notes its intention "for the diagnosis of diseases of the teeth, jaw, and oral structures."
No
The device description explicitly states "Digital Dental Intraoral X-Ray Sensor," indicating a hardware component (the sensor) is part of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens taken from the human body (like blood, urine, tissue). The BIO-RAY SDX system works with dental x-ray photos, which are images of the teeth, jaw, and oral structures within the body, not specimens taken from the body.
- The intended use is for diagnosis based on imaging data. The system collects and converts x-ray images for viewing and manipulation by dentists for diagnosis. This is a form of medical imaging, not in vitro testing.
Therefore, the BIO-RAY SDX digital x-ray system falls under the category of a medical imaging device, not an IVD.
N/A
Intended Use / Indications for Use
The BIO-RAY SDX digital x-ray system is intended to be used with standard x-ray systems to collect dental x-ray photos and convert them into electronic data that may be stored, viewed, and manipulated by dentists for the diagnosis of the tecth, jaw and oral structures with the use of computer imaging sollware provided by other 30 parties, readily available from numerous sources.
Product codes
MUH
Device Description
Digital Dental Intraoral X-Ray Sensor This device is intended to be used for the dental radiographic examination for the diagnosis of diseases of the teeth, jaw, and oral structures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray
Anatomical Site
tecth, jaw and oral structures
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dentists
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.1800 Extraoral source x-ray system.
(a)
Identification. An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.(b)
Classification. Class II.
0
FER 8 2006
Image /page/0/Picture/2 description: The image shows the logo for Sigma Biomedics. The logo consists of two hexagons, one filled in black and the other outlined in black. To the right of the hexagons is the text "SIGMA BIOMEDICS" in a sans-serif font. The word "SIGMA" is above the word "BIOMEDICS".
510(k) Summary
Sigma Biomedics, Inc. 65 E. Palatine Rd., Blg.#201 Prospect Heights, IL 60070 847-419-0669
Name of Contact person: Kim Antol
Date Summary was prepared: January 9, 2006
Name of Device
| Trade/Proprietary Name: | Bio-Ray SDX Digital X-Ray System |
|---|---|
| Common/Usual Name: | Intraoral X-Ray Sensor |
| Classification Name: | Extraoral Source Dental X-Ray, Digital System |
The legally marketed device to which we are claiming equivalence [807.92(a)(3)]
Description of the Device:
Digital Dental Intraoral X-Ray Sensor This device is intended to be used for the dental radiographic examination for the diagnosis of diseases of the teeth, jaw, and oral structures.
65 E. Palatine Rd., #201, Prospect Heights, 11, 60070, (800) 331-6077, (847) 419-0669, Fax-(847) 419-0675
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes extending from its back, symbolizing growth and progress. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 8 2006
2006
Ms. Kim Antol President Sigma Biomedics, Inc. 65 E. Palatine Rd., Bldg. 201 PROSPECT HEIGHTS IL 60070-1845 Re: K060179 Trade/Device Name: BIO-Ray SDX Digital X-Ray System Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH Dated: January 20, 2006 Received: January 24, 2006
Dear Ms. Antol:
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 (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 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.
2
This letter will allow you to begin 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 one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 (301) 443-6597 or at its Internet address
http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. Brogdon
Nanev C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): K060179
Device Name: BIO-Ray SDX Digital X-Ray system
Indications For Use:
The BIO-RAY SDX digital x-ray system is intended to be used with standard x-ray systems to collect dental x-ray photos and convert them into electronic data that may be stored, viewed, and manipulated by dentists for the diagnosis of the tecth, jaw and oral structures with the use of computer imaging sollware provided by other 30 parties, readily available from numerous sources.
This device is only to be sold as a prescription device sold to doctors or dental dealers selling directly to doctors,
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)
David A. Lippman
(Division Sign-Off) Division of Reproductive, Abdomina and Radiological Devices 510(k) Number _
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