(12 days)
Not Found
No
The summary does not mention AI, ML, or any related terms, and the device description is a standard digital X-ray sensor.
No.
The device is used for diagnosis, not for treatment or therapy. It collects and processes X-ray data for dentists to diagnose diseases.
Yes
The "Intended Use / Indications for Use" states that the electronic data collected from the X-ray photos "may be stored, viewed, and manipulated by dentists for the diagnosis of diseases of the teeth, jaw, and oral structures." This explicit mention of "diagnosis of diseases" indicates that the device is used for diagnostic purposes.
No
The device description explicitly states "Digital Dental intraoral Xray Sensor," which is a hardware component. The intended use also describes collecting dental x-ray photos, which requires a physical sensor.
Based on the provided information, the CDX Digital X-ray Imaging System 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 CDX system collects dental x-ray photos and converts them into electronic data for viewing and manipulation. This is an imaging system that captures images of the internal structures of the body.
- Intended Use: The intended use is for the diagnosis of diseases of the teeth, jaw, and oral structures based on these images. This is a diagnostic imaging function, not an in vitro test.
The device operates by capturing images of the body directly, not by analyzing samples taken from the body. Therefore, it falls under the category of medical imaging devices, not IVDs.
N/A
Intended Use / Indications for Use
The CDX Digital X-ray Imaging System is intended to be used with standard X-ray systems to collect dental x-rays photos and convert them into electronic data that may be stored, viewed, and manipulated by dentists for the diagnosis of diseases of the teeth, jaw, and oral structures.
Product codes
90 MUH
Device Description
Digital Dental intraoral Xray Sensor
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
teeth, 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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
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
K04-2736
Premarket Notification -CNC Imaging, Inc.
OCT 1 3 2004
SUMMARY
Submitter's Information: CNC Imaging, Inc. 679-E South State College Blvd Fullerton, CA 92831 714-447-9560 714-447-9572
Name of contact person:
KORINA A. AKHONDZADEH REGULATORY SPECIALISTS, INC. 1559 Eden Court San Elijo Hills, CA 92078 760-798-9642 korina@regulatoryspecialists.com
Date the summary was prepared: September 27, 2004
Name of Device:
| Trade/Proprietary Name: | CDX Digital X-ray Imaging System |
|---|---|
| Common/Usual Name: | Intraoral Digital 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 Xray Sensor
This device is intended to be used for dental radiographic examination for the diagnosis of diseases of the teeth, jaw, and oral structures.
679-E South State College Blvd. Fullerton, CA 92831 Tel: 714-447-9560 Fax: 714-447-9572 www.cncimaging.com
1
Indications:
Indications for Use (from labeling): The CDX Digital X-ray Imaging System is intended to be used with standard X-ray systems to collect dental x-rays photos and convert them into electronic data that may be stored, viewed, and manipulated by dentists for the diagnosis of diseases of the teeth, jaw, and oral structures
Summary of the technological characteristics of our device compared to the predicate device:
The predicate Dr. Suni Digital Radiography System K021718, manufactured by Suni Imaging Microsystems, Inc. and CNC Imaging, Inc. CDX Digital X-ray Imaging System were compared and found to have similar technological characteristics and to be equivalent.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes around a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus. The seal is in black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 3 2004
CNC Imaging, Inc. % Ms. Korina A. Akhondzadeh Regulatory Specialist Regulatory Specialist, Inc. 1559 Eden Court SAN ELIJO HILLS CA 92078
Re: K042736 Trade/Device Name: CDX Digital X-ray
Imaging System. Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system
Regulatory Class: II Product Code: 90 MUH Dated: September 28, 2004 Received: October 1, 2004
Dear Ms. Akhondzadeh: 1
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we have reviewed your becally be (is) probantially equivalent (for the indications for use stated in above and nave determined the ad predicate devices marketed in interstate commerce prior to the enclosule) to tegary maneled problem of the Medical Device Amendments, or to devices that have been May 20, 1770, the Chacinent acts 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 do not require approval or a premanet approvisions of the Act. The general controls provisions of the Act device, subject to the general controls proof, 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 If your de vice is classified (300 acon additional controls. Existing major regulations affecting your Apploval), it they be subject to address 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 I lease be advised mar i Dr. I o iseas your device complies with other requirements of the Act or any For has made a determination and Josefed by other Federal agencies. You must comply with all the I cut at statues and regulations and limited to registration and listing (21 CFR Part 807); labeling ACS Tequirements, mediating bactive practice requirements as set forth in the quality systems (QS) (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) I his letter will anow you to ogin manusing of substantial equivalence of your device to a legally premarket nothleation: The PDA maing of oation 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 If you desire specific advice for your ac-resther mumbers, 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 Also, process note the regulation on your responsibilities under the Act from the 807.77). Tou may obtain Janufacturers, International and Consumer Assistance at its toll-free number (800) DVVSloll or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmadsmamain.html
Sincerely yours,
Nancy C. Brogdon
Nancy C. I Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
CNC Imaging
| Page 1 of 1 | |
|---|---|
| 510(k) Number (if known): | K042736 |
| Device Name: | |
| Indications For Use: |
The CDX Digital X-ray Imaging System is intended to be used with standard digital X-ray systems to collect dental x-rays photos and convert them into electronic impulses that may be stored, viewed, and manipulated by dentists for the diagnosis of diseases of the teeth, jaw, and oral structures.
| Prescription Use
(Per 21 CFR 801.109) | OR | Over-The-Counter Use
(Optional Format 1-2-96) |
| ------------------------------------------ | ---- | -------------------------------------------------- |
|---|
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C Brogdon
(Division Sign-Off)
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number [K042736](https://510k.innolitics.com/search/K042736)