(73 days)
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No
The summary describes a digital radiography sensor that replaces film/screen systems. There is no mention of AI, ML, or advanced image processing that would suggest the use of such technologies.
No.
The device is described as an "Imaging Sensor" for "digital image capture" in "diagnostic procedures," indicating its role in image acquisition for diagnosis, not treatment.
Yes
The device is described as intended to replace film/screen systems in "all general-purpose diagnostic procedures," indicating its role in diagnosis.
No
The device description explicitly states it is a "Direct Digital Radiography CCD Imaging Sensor," which is a hardware component used for image capture.
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. The intended use of this device is to capture digital images for conventional radiographic examinations, which involves imaging the inside of the body directly, not analyzing samples taken from the body.
- The description focuses on imaging technology and its application in radiology. There is no mention of analyzing biological samples, reagents, or any other components typically associated with IVD testing.
Therefore, this device falls under the category of a medical imaging device, specifically a digital radiography sensor.
N/A
Intended Use / Indications for Use
The Direct Digital Radiography CCD Imaging Sensor, NAOMI provides digital image capture for conventional film / screen radiographic examinations. The device is intended to replace radiographic film / screen systems in all general-purpose diagnostic procedures. "The device must not be used for primary diagnosis in mammography."
Product codes
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
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Anatomical Site
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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)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
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Image /page/0/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
RF System Lab % Mr. Claude D. Berthoin President Video Dental Concepts, Inc. 110 E. Granada Blvd., Suite 207 ORMOND BEACH FL 32175
AUG 23 2013
Re: K062376
Trade/Device Name: Direct Digital Radiography CCD Imaging Sensor NAOMI Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: September 29, 2006 Received: October 2, 2006
Dear Mr. Berthoin:
This letter corrects our substantially equivalent letter of October 27, 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 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 requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro 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 Division 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. Morr Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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INDICATION FOR USE
RF SYSTEMLAB APPLICANT: 510(K) NUMBER (IF KNOWN):
DIRECT DIGITAL RADIOGRAPHY CCD IMAGING SENSOR NAOMI DEVICE NAME:
INDICATION FOR USE:
The Direct Digital Radiography CCD Imaging Sensor, NAOMI provides digital image capture for conventional film / screen radiographic examinations. The device is intended to replace radiographic film / screen systems in all general-purpose diagnostic procedures.
"The device must not be used for primary diagnosis in mammography."
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED.
Concurrence of CDRH, Office of Device Evaluation (ODE).
Prescription Use
Nancy C. Broydon
(Division Sign-O Division of Reproductive, A and Radiological Device 510(k) Number _