(147 days)
No
The summary describes a digital upgrade to an existing x-ray system, focusing on replacing the film receptor with a digital one. There is no mention of AI, ML, image processing beyond basic digital conversion, or any performance metrics typically associated with AI/ML algorithms.
No
The device is an x-ray system used for diagnostic imaging, not for treating diseases or conditions.
No
The device produces digital radiographs, which are images. It does not analyze these images or provide any diagnostic output, thus it is not a diagnostic device itself, but rather an imaging device used in the diagnostic process.
No
The device description explicitly states it is a "panoramic extraoral source dental x-ray system" and mentions replacing a film receptor with a digital receptor (CCD), indicating it is a hardware device that produces digital images, not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body.
- Device Function: The Cranex Basex D and Cranex Excel D are imaging devices. They use X-rays to create images of structures within the body (dentition, TM-joints, etc.). This is an in vivo (within the living body) process, not in vitro.
- Intended Use: The intended use clearly states "producing digital radiographs of dentition, TM-joints and other oral structures." This is a diagnostic imaging function, not an in vitro laboratory test.
Therefore, based on the provided information, this device falls under the category of medical imaging equipment, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Cranex Basex D and Cranex Excel D dental panoramic equipments are indicated for dental radiographic examinations by producing digital radiographs of dentition, TM-joints and other oral structures.
Product codes
MUH, EHD
Device Description
Cranex Basex D and Cranex Excel D are panoramic extraoral source dental x-ray systems, which produce digital images of dentition. They are modified from the existing Soredex dental panoramic x-ray systems (K880982) by substantially replacing the film image receptor with a digital receptor(CCD). The technique factor settings are constant for the x-ray tube anode voltage (65kV) and current (6 mA DC).
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 Basex D and Cranex Excel D correspond with the intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
Image /page/0/Picture/0 description: The image shows the logo for Soredex. The logo consists of the word "SOREDEX" in a stylized font, with a black, curved shape above it. The curved shape resembles a sail or a stylized wave.
JUL 1 3 2004
510(k) Summary
Kouo382
Date February 10, 2004
Submitters Information
Soredex Instrumentarium Corporation Elimaenkatu 22 B 00510 Helsinki Finland Phone: +358 10 394820 Fax .: +358 9 7015261 Contact: Kai Lanér
Trade Name
Cranex Basex D or Cranex Excel D
Common Name
Dental panoramic x-ray equipment, digital
Classification
System, X-Ray, Extraoral Source, Digital / MUH
Predicate Device
We consider that Cranex Basex D and Cranex Excel D are substantially equivalent in design, composition and function with Orthophos DS (K983057 & K972312).
Product Description
Cranex Basex D and Cranex Excel D are panoramic extraoral source dental x-ray systems, which produce digital images of dentition. They are modified from the existing Soredex dental panoramic x-ray systems (K880982) by substantially replacing the film image receptor with a digital receptor(CCD). The technique factor settings are constant for the x-ray tube anode voltage (65kV) and current (6 mA DC),
Intended Use
The Cranex Basex D and Cranex Excel D dental panoramic equipments are indicated for dental radiographic examinations by producing digital radiographs of dentition, TM-joints and other oral structures.
Performance data
Verification and validation testing was successfully performed to confirm that Cranex Basex D and Cranex Excel D correspond with the intended use.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Kai Lanér Soredex Instrumentarium Corporation Ekimaenkatu 22B FIN 00510 Heksinki FINLAND
Re: K040382
Trade/Device Name: Cranex Basex D or Cranex Excel D Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system
Regulatory Class: II Product Code: 90 EHD Dated: June 11, 2004 Received: June 14, 2004
Dear Ms. 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 (PMA), 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.
JUL 1 3 2004
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 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. Broughton
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
510 (k) NUMBER : KOY 0 382
Cranex Basex D and Cranex Excel D DEVICE NAME :
INDICATIONS FOR USE :
The Cranex Basex D and Cranex Excel D dental panoramic equipments are indicated for dental radiographic examinations by producing digital radiographs of dentition, TM-joints and other oral structures.
Prescription Use
Nancy C. Bragdon
(Division Sign-Off)
Division of Reproductive. Abdominal,
and Radiological Devices
K040382
UK Number