(20 days)
No
The description focuses on hardware modifications (sensor type, docking station) and basic image capture/digitization. There is no mention of AI/ML algorithms for image analysis, interpretation, or other functions. The "image enhancement" mentioned is likely standard digital processing, not AI/ML-driven.
No
The device is described as an imaging system used with dental X-ray systems to capture and process images. It does not appear to provide any therapeutic effect.
Yes
The device is an imaging system (digital dental X-ray) that captures and processes images which are then sent to a computer screen for presentation. This output is used to aid diagnosis.
No
The device description explicitly states the system incorporates a new sensor component (CMOS sensor) and a docking station, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the system is for capturing and processing digital dental X-ray images. This is a diagnostic imaging system, not a system designed to perform tests on biological samples (like blood, urine, or tissue) outside of the body.
- Device Description: The description focuses on the technology used to capture and process X-ray images (CMOS sensor, digitization, display on a computer screen). This aligns with an imaging device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information based on in vitro testing.
Therefore, the EVA Digital Dental Imaging System falls under the category of a medical imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The EVA Digital Dental Imaging System is intended to be used with standard digital dental X-ray systems and computer stations for system operation, archive data storage, input capture and enhancement, and patient data and support.
Product codes
EHD
Device Description
The EVA System (previously named the Sens-A-Ray System) has been modified to incorporate a new sensor component and docking station. The proposed EVA System is essentially identical in intended use and fundamental technology to the parent Sens-A-Ray System described in K923067. The modifications are limited to changing the sensor from a CCD Sensor to a Complimentary Metal Oxide Semiconductor (CMOS) sensor and adding a docking station. As with the original Sens-A-Ray Sensor, the CMOS sensor when exposed to radiation captures the image in the form of a charge pattern on its surface. The resulting electronic output signals are digitized by a processor and sent to a computer screen for image presentation. The EVA System Sensor and supporting electronics are identical in intended use and fundamental technology to the parent Sens-A-Ray Sensor and supporting electronics.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
Dental
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
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.
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K030647 page 1 of 2
Special 510(k) Summary for EVA Digital Dental Imaging System
MAR 2 0 2003
SPONSOR 1.
AFP Imaging Corporation 250 Clearbrook Road Elmsford, NY 10523
Contact Person: David Vozick (914) 592-6100 Telephone:
Date Prepared: February 27, 2003
DEVICE NAME 2.
| Proprietary Name: | EVA Digital Dental X-Ray System |
|---|---|
| Common/Usual Name: | Accessory to Extraoral X-Ray System |
| Classification Name: | Extraoral Source X-Ray System Accessory |
PREDICATE DEVICES 3.
AFP Imaging Sens-A-ray System
INTENDED USE 4.
The EVA Digital Dental Imaging System is intended to be used with standard digital dental X-ray systems and computer stations for system operation, archive data storage, input capture and enhancement, and patient data and support.
DEVICE DESCRIPTION ડ.
The EVA System (previously named the Sens-A-Ray System) has been modified to incorporate a new sensor component and docking station. The proposed EVA System is essentially identical in intended use and fundamental technology to the parent Sens-A-Ray System described in K923067. The modifications are limited to changing the sensor from a CCD Sensor to a Complimentary Metal Oxide Semiconductor (CMOS) sensor and adding a docking station. As with the original Sens-A-Ray Sensor, the CMOS sensor when exposed to radiation captures the image in the form of a charge pattern on its surface. The resulting
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page 2 of 2
electronic output signals are digitized by a processor and sent to a computer screen for image presentation. The EVA System Sensor and supporting electronics are identical in intended use and fundamental technology to the parent Sens-A-Ray Sensor and supporting electronics.
· TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.
The modified EVA System and the predicate Sens-A-Ray System both include the ProImage application software package. Both systems allow images to be captured, digitized, and uploaded to a standard computer. Both systems consist of an X-ray sensitive solid state imaging array enclosed in a capsule connected via cable to digitizing and control electronics which in turn interface to a computer via a standard interface. The only differences between the predicate and the proposed systems is the EVA system uses a CMOS imager chip in place of the CCD sensor as used in the predicate Sens-A-Ray and the docking station in place of the Imager and Image Grabber. The CMOS Sensor achieves a larger image area with higher resolution and lower power requirements. The EVA's computer hardware interface replaces the obsolete ISA interface used in the Sens-A-Ray with a standard USB interface. The Docking Station includes the commonly used USB interface instead of the ISB for communication between the sensor and the cable.
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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features an abstract image of an eagle with three stripes representing its wings. The seal is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 0 2003
Re: K030647
AFP Imaging % Ms. Mary McNamara-Cullinane, RAC Staff Consultant Medical Device Consultants, Inc. 49 Plain Street NORTH ATTLEBORO MA 02760
Trade/Device Name: EVA Digital Dental Imaging System Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: 90 EHD Dated: February 27, 2003 Received: February 28, 2003
Dear Ms. McNamara-Cullinane:
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 (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.
3
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 the letter:
| 8xx. 1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained 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/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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510(k) Number (if known): K 030647
Device Name: EVA Digital Dental Imaging System
Indications for Use:
The EVA Digital Dental Imaging System is intended to be used with standard digital dental X-ray systems and computer stations for system operation, archive data storage, input capture and enhancement, and patient data and support.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C Brogdon
Division Sign-Off
Prescription Use
(Per 21 CFR 801.109) $\checkmark$
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
AFP Imaging Special 510(k) EVA System
February 27, 2003