(88 days)
Not Found
No
The device description focuses on automated selection of preselected image processing parameters based on exam type and patient age, which is a rule-based automation, not AI/ML. There is no mention of learning or adaptive algorithms.
No.
The device is used to provide diagnostic images, not to treat any condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that "The ADC Dental is indicated for use to provide diagnostic quality images to aid in physician or dentist diagnosis." This directly indicates its role in the diagnostic process.
No
The device description explicitly states that the ADC Dental is identical in hardware and software to the predicate device, the ADC Compact Plus, which is described as a computed radiography imaging system utilizing an "imaging plate" and a device that scans it with a laser. This indicates the device includes significant hardware components.
Based on the provided information, the ADC Dental 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.
- ADC Dental Function: The ADC Dental is an imaging system that uses X-rays to create diagnostic images of the extraoral dental and maxillofacial areas. It works by capturing X-ray energy on an imaging plate and converting it into a digital image.
- Lack of Biological Sample Analysis: The device does not analyze any biological samples from the patient. It directly interacts with the patient's body using X-rays to produce an image.
Therefore, the ADC Dental falls under the category of medical imaging devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The ADC Dental is indicated for use to provide diagnostic quality images to aid in physician and dentist diagnosis. The ADC Dental is intended to be used in extraoral dental and maxillofacial imaging applications.
Product codes
90 MUH
Device Description
The ADC Compact Plus, the predicate device, is a computed radiography imaging system. Instead of screens and photographic film for producing the diagnostic image, the ADC Compact system utilizes an "imaging plate," a plate coated with photo-stimulatable storage phosphors that are sensitive to X-rays and capable of retaining a latent image. This imaging plate is inserted into a device that scans it with a laser and releases the latent image in the form of light which is converted into a digital bit stream. The bit stream of image data is stored locally and can also be stored in the PACS network in DICOM format.
The ADC Dental is identical in hardware and software to the ADC Compact Plus. The only difference is in a data file provided that is accessed by the (unchanged) software, where preselected image processing parameters are paired with typical dental exposure Rather than entering the exposure parameters by exam type. parameters manually, as would be the case for dental/maxillofacial exams using the ADC Compact Plus, the user would simply select the exam type and patient age, and the proper image processing parameters would be selected automatically and applied to "developing" the image.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Computed Radiography (X-ray)
Anatomical Site
extraoral dental and maxillofacial
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician or dentist diagnosis. The clinical environment.
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
The ADC Dental was tested in a clinical environment and it was found to be preferred to traditional imaging techniques.
Key Metrics
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.
0
510(k) Summary
ADC Dental
Common/Classification Name: Computed Radiography, 21 CFR 892.1630
Agfa Corporation 10 South Academy Street Greenville, SC 29602-9048
Contact: Jeff Jedlicka, Prepared: May 8, 2002
LEGALLY MARKETED PREDICATE DEVICES A.
The predicate device is the previous version of the same device, namely the ADC Compact Plus, which was cleared by FDA on 28 September 2001 as K013138. For the indications for use of acquiring digital dental/maxillofacial radiographic images, the ADC Dental is substantially equivalent to the Schick Technologies CDR-Pan Model 4700, which was cleared for marketing by FDA on December 11, 1998 as K982661.
DEVICE DESCRIPTION B.
The ADC Compact Plus, the predicate device, is a computed radiography imaging system. Instead of screens and photographic film for producing the diagnostic image, the ADC Compact system utilizes an "imaging plate," a plate coated with photo-stimulatable storage phosphors that are sensitive to X-rays and capable of retaining a latent image. This imaging plate is inserted into a device that scans it with a laser and releases the latent image in the form of light which is converted into a digital bit stream. The bit stream of image data is stored locally and can also be stored in the PACS network in DICOM format.
The ADC Dental is identical in hardware and software to the ADC Compact Plus. The only difference is in a data file provided that is accessed by the (unchanged) software, where preselected image processing parameters are paired with typical dental exposure Rather than entering the exposure parameters by exam type. parameters manually, as would be the case for dental/maxillofacial exams using the ADC Compact Plus, the user would simply select the exam type and patient age, and the proper image processing parameters would be selected automatically and applied to "developing" the image.
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C. INTENDED USE
Koli542-
The ADC Dental is indicated for use to provide diagnostic quality images to aid in physician and dentist diagnosis. The ADC Dental is intended to be used in extraoral dental and maxillofacial imaging applications.
D. SUBSTANTIAL EQUIVALENCE SUMMARY
The ADC Dental has similar indications for use as the legally marketed predicate devices. The differences do not affect the intended diagnostic effect. The ADC Dental has the same (identical) technological characteristics as the predicate device. This premarket notification has described the characteristics of the ADC Dental in sufficient detail to assure substantial equivalence.
ட். TECHNOLOGICAL CHARACTERISTICS
The technological characteristics are identical in the proposed and predicate devices.
F. TESTING
The ADC Dental was tested in a clinical environment and it was found to be preferred to traditional imaging techniques.
CONCLUSIONS G.
This pre-market submission has demonstrated Substantial Equivalence as defined and understood in the Federal Food Drug and Cosmetic Act and various guidance documents issued by the Center for Devices and Radiological Health.
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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 features a stylized eagle with three stripes extending from its back, representing the department's commitment to health, human services, and well-being. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
AUG 0 6 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Jeff Jedlicka Manager of Regulatory Affairs and Compliance Agfa Corporation 10 South Academy Street GREENSVILLE SC 29602
Re: K021542 Trade/Device Name: ADC Dental Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: 90 MUH Dated: May 9, 2001 Received: May 10, 2002
Dear Mr. Jedlicka:
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 (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.
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This letter will allow you to begin marketing your device as described in your 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:
| 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" (21 CFR Part 807.97). 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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STATEMENT OF INDICATIONS FOR USE
510(k) Number (if known): KO21542
Device Name:
Indications For Use:
The ADC Dental is indicated for use to provide diagnostic quality images to aid in physician or dentist diagnosis. The ADC Dental is intended to be used in extraoral dental and maxillofacial imaging applications.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use V (Per 21 CFR 801.109)
OR
Over-The-Counter Use
David A. Seymour
and Ra 510k) Ne