(29 days)
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No
The provided 510(k) summary does not contain any mention of AI, ML, deep learning, or any related terms, nor does it describe functionalities typically associated with AI/ML in medical imaging (e.g., automated detection, segmentation, or analysis). The description focuses solely on the device's function as an X-ray system.
No.
The device is described as an X-ray system for imaging purposes, which is diagnostic, not therapeutic.
Yes
Explanation: The device is an X-ray system used for "imaging of the dento-maxillo-facial area." Obtaining images of internal body structures like this is a fundamental step in diagnosing medical conditions by allowing healthcare professionals to visualize and evaluate the anatomical site for abnormalities or pathology.
No
The device is described as an X-ray system, which inherently involves hardware components for generating and capturing X-rays. The summary does not mention any software-only functionality.
Based on the provided information, the Kodak 9000C digital dental panoramic and cephalometric X-ray system is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to be an "extraoral source of X-rays for imaging of the dento-maxillo-facial area." This describes a device used to create images of the body, which is a characteristic of an in vivo diagnostic device (used within a living organism), not an in vitro diagnostic device (used to examine samples taken from the body).
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information about a patient's health status based on sample analysis
Therefore, the Kodak 9000C is an in vivo diagnostic imaging device, specifically an X-ray system for dental and maxillofacial imaging.
N/A
Intended Use / Indications for Use
Kodak 9000C digital dental panoramic and cephalometric X-ray system is to be used as an extraoral source of X-rays for imaging of the dento-maxillo-facial area.
Product codes
MUH
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
X-ray
Anatomical Site
dento-maxillo-facial area
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/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 forming its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 9 2008
Ms. Marie-Pierre Labat-Camy Regulatory Affairs Manager Trophy, A Subsidairy of Carestream Health, Inc. 4, rue F. Pelloutier-Croissy-Beaubourg 77435 Marne La Vallée Cedex 2 FRANCE
Re: K080889
Trade/Device Name: Kodak 9000C Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH Dated: March 28, 2008 Received: April 1, 2008
Dear Ms. Labat-Camy:
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.
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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.
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 Center for Devices and Radiological Health's (CDRH's) 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" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrb/industry/support/index.html.
Sincerely vours.
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
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Special 510 (k) : Kodak 9000 C
INDICATIONS FOR USE
510 (k) Number :
Device Name : Kodak 9000C
Indications For Use :
:
Kodak 9000C digital dental panoramic and cephalometric X-ray system is to be used as an extraoral source of X-rays for imaging of the dento-maxillo-facial area.
| Prescription Use X (21 CFR 801 Subpart D ) | and/or | Over-The-Counter Use_ (21 CFR 801 Subpart C ) |
|---|---|---|
| ------------------------------------------------------------------------ | -------- | -------------------------------------------------- |
(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
| 510(k) Number | K080889 |
|---|---|
| --------------- | --------- |
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Concurence of CDRH, Office of Device Evaluation (ODE)