(16 days)
Not Found
No
The summary describes a standard digital dental x-ray system with no mention of AI or ML capabilities in its intended use, device description, or performance studies.
No
The device is indicated for producing digital radiographs for examination, which is a diagnostic purpose, not a therapeutic one. It does not treat or cure any condition.
No
The device is described as producing digital radiographs for examinations, which is an imaging device, not a diagnostic device. Diagnostic devices interpret images or data to provide a diagnosis.
No
The device description clearly states it is an "extraoral source dental x-ray system," which is a hardware device. It also mentions utilizing a "digital image receptor (CCD)," another hardware component.
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 such as blood, urine, or tissue that have been taken from the human body. They are used to detect diseases, conditions, or infections.
- Device Function: The Cranex D dental panoramic equipment is an imaging device that uses X-rays to produce digital radiographs of anatomical structures (dentition, TM-joints, etc.). It does not analyze biological samples taken from the body.
- Intended Use: The intended use clearly states "dental radiographic examinations" and "producing digital radiographs." This is a diagnostic imaging function, not an in vitro diagnostic function.
Therefore, the Cranex D is a medical device, specifically a diagnostic imaging device, but it does not fall under the category of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Cranex D dental panoramic equipment is indicated for dental radiographic examinations by producing digital radiographs of dentition, TM-joints and other oral structures. The Cranex D is upgradeable for cephalometric radiography and examinations related thereto.
Product codes (comma separated list FDA assigned to the subject device)
EHD
Device Description
Cranex D is a panoramic extraoral source dental x-ray system, which produces digital images of dentition. The device is upgradeable for cephalometric radiography. Cranex D utilizes digital image receptor(CCD).
The technique factor settings for panoramic examinations are: 57 – 85 kVp, 10 mA DC and 17.6 s max. The technique factor settings for cephalometric radiographs are: 60 - 85 kVp, 10 mA DC and 8 - 20 s.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray
Anatomical Site
dentition, TM-joints and other oral structures
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)
Verification and validation testing was successfully performed to confirm that Cranex D corresponds with the intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
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
Image /page/0/Picture/0 description: The image shows the logo for Soredex. The logo features the word "SOREDEX" in a bold, sans-serif font. Above the text is a black graphic that resembles a stylized satellite dish or antenna. The overall design is simple and modern.
510(k) Summarv
DEC 17 2004
Date
November 26, 2004
Submitters Information
Soredex Instrumentarium Corporation Nahkelantie 160 FIN-04300 Tuusula Finland Phone: +358 10 394820 Fax .: Contact: Kai Lanér
Trade Name
Cranex D
Common Name
Dental panoramic x-ray equipment, digital, upgradeable for cephalometric radiography
Classification
Unit, x-ray, extraoral, with timer / EHD
Predicate Device
We consider that Cranex D is substantially equivalent in design, composition and function with Orthophos DS / DS Ceph (K972312) and with Cranex Basex D or Cranex Excel D (K040382).
Product Description
Cranex D is a panoramic extraoral source dental x-ray system, which produces digital images of dentition. The device is upgradeable for cephalometric radiography. Cranex D utilizes digital image receptor(CCD).
The technique factor settings for panoramic examinations are: 57 – 85 kVp, 10 mA DC and 17.6 s max. The technique factor settings for cephalometric radiographs are: 60 - 85 kVp, 10 mA DC and 8 - 20 s.
Intended Use
The Cranex D dental panoramic equipment is indicated for dental radiographic examinations by producing digital radiographs of dentition, TM-joints and other oral structures. The Cranex D is upgradeable for cephalometric radiography and examinations related thereto. .
Performance data
Verification and validation testing was successfully performed to confirm that Cranex D corresponds with the intended use.
1
Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 17 2004
Mr. Kai Lanér Soredex Instrumentarium Corporation Nahkelantie 160 FIN 00430 Tuusula FINLAND
Re: K043307 Trade/Device Name: Cranex D Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: 90 EHD Dated: November 26, 2004 Received: December 1, 2004
Dear Mr. Lanér:
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 (Premarket Approval), it may be subject to such 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.
2
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 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 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrl/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
3
Page 1 of 1
KO43307 510 (k) NUMBER :
Cranex D DEVICE NAME :
INDICATIONS FOR USE :
.
The Cranex D dental panoramic equipment is indicated for dental radiographic examinations by producing digital radiographs of dentition, TM-joints and other oral structures. The Cranex D is upgradeable for cephalometric radiography and examinations related thereto.
Damil A. Shegmm
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
Prescription Use