(149 days)
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Not Found
No
The summary does not mention any AI or ML terms, image processing, or performance studies typically associated with AI/ML devices.
No
The device is indicated for generating radiographic images for diagnosis, not for treating diseases or conditions.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is intended for "diagnosis of diseases of the teeth, jaw, and oral structures," which indicates a diagnostic purpose.
No
The device description explicitly states "Solid State X-Ray Imaging Device," indicating a hardware component for image acquisition.
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 description clearly states that this device is an "X-Ray Imaging Device" used to generate "radiographic images of the dento-maxilofacial region." This is an in vivo imaging process, meaning it is performed on a living patient, not on a sample taken from the patient.
- Intended Use: The intended use is for "dental examination and diagnosis of diseases of the teeth, jaw, and oral structures" based on these radiographic images. This is a diagnostic process, but it's based on imaging the body directly, not on analyzing a biological sample.
Therefore, the ADR Plus SSXI Imaging Device falls under the category of a medical imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The ADR Plus SSXI Imaging Device for X-ray systems such as X-CALIBER, X-CALIBER CM, ANA-BEL and ANA-BEL CM, a Solid State X-Ray Imaging Device is indicated for use as a generator of radiographic images of the dento-maxilofacial region and is intended to replace conventional radiographic film for dental examination and diagnosis of diseases of the teeth, jaw, and oral structures.
Product codes
MUH, EHD, MQB
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
X-ray
Anatomical Site
dento-maxilofacial region, teeth, jaw, oral structures
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
Image /page/0/Picture/0 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 an eagle with its wings spread, and its head turned to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Takara Belmont USA, Inc. Robert Schiff, Ph.D. President Schiff & Company 1129 Bloomfield Avenue WEST CALDWELL NJ 07006
AUG 21 2013
Re: K041834
Trade/Device Name: ADR Plus SSXI Imaging Device for X-ray Systems Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH, EHD, and MQB Dated: October 19, 2004 Received: October 20, 2004
Dear Dr. Schiff:
This letter corrects our substantially equivalent letter of December 3, 2004.
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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of
1
medical device-related adverse events) (21 CFR 803); and good manufacturing practice medious do roo realted as not be quality systems (QS) regulation (21 CFR Part 820). This letter requirences as bet form in and one device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed nonicate 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 Parts 801 and 11 you desire spoolily darrow to your viro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Four inay of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours,
Janine M. Morris
Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
2
. AND ANA-
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): Device Name:
Not assigned yet ADR Plus SSXI Imaging Device for X-ray systems such as X-CALIBER, X-CALIBER CM, ANA-BEL and ANA-BEL CM
Indications for Use:
The ADR Plus SSXI Imaging Device for X-ray systems such as X-CALIBER, X-CALIBER CM, ANA-BEL and ANA-BEL CM, a Solid State X-Ray Imaging Device is indicated for use as a generator of radiographic images of the dento-maxilofacial region and is intended to replace conventional radiographic film for dental examination and diagnosis of diseases of the teeth, jaw, and oral structures.
Prescription Use X
(Per 21 CFR 801 Subpart D)
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)
Nancyic broadon
(Division Sign-Off) ()
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K041834
SUBMITTED BY SCHIFF & COMPANY, WEST CALDWELL, NJ
JC \Server\sorver\TakaraBetmont\SSXI\2004-07-01-SSXI-510k.doc