(117 days)
Not Found
No
The summary describes a standard intraoral camera for image capture and display, with no mention of AI or ML for image analysis, diagnosis, or other functions.
No
The device is used for imaging and assessment, not for treating or curing a disease or condition.
Yes
The device is described as assisting in the "assessment of the overall oral health of the patient" and allowing practitioners to "view and magnify regions of the oral cavity," which are diagnostic actions.
No
The device description explicitly states that the Kodak 1500 includes a camera/handpiece assembly, docking station, and embedded acquisition software, indicating it is a hardware device with accompanying software.
Based on the provided information, the Kodak 1500 Intraoral Camera is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The Kodak 1500 Intraoral Camera directly images the inside and outside of the mouth. It does not analyze biological samples.
- The intended use and indications for use clearly state that the device is for viewing and capturing images of intraoral and extraoral anatomy. This is for visual assessment, communication, and documentation, not for analyzing biological specimens.
- The device description focuses on the camera, docking station, and software for image acquisition and display. There is no mention of reagents, assays, or any components typically associated with IVD testing.
In summary, the Kodak 1500 Intraoral Camera is a medical imaging device used for visual examination, not an in vitro diagnostic device used for testing biological samples.
N/A
Intended Use / Indications for Use
The Kodak 1500 Intraoral Camera (Kodak 1500) is intended for chairside use by dentists and dental sub-specialists during oral health examinations. It provides magnified digital color images of intraoral or extraoral anatomy via a video monitor or Personal Computer (PC). Both still and video images can be captured and stored. The device allows practitioners to view the interior of the oral cavity and assist in the assessment of the overall oral health of the patient. The Kodak 1500 also provides a tool for communicating treatment requirements or results by allowing practitioner and patient to view areas of concern together, before and after procedures.
The Kodak 1500 Intraoral Camera is indicated for use by health professionals in viewing and capturing intraoral or extraoral color video images for the purposes of:
- Allowing practitioners to view and magnify regions of the oral cavity
- Assisting communications with the patient by providing a view of treatment areas before and after a procedure
- Providing images for documentation in patient records.
Product codes (comma separated list FDA assigned to the subject device)
EIA
Device Description
The Kodak 1500 includes a camera/handpiece assembly, docking station, and embedded acquisition software. It is available in two versions: Kodak 1500 Intraoral Camera – wired and Kodak 1500 Intraoral Camera – wireless. The wireless version, in which the handpiece transmits the acquired image data to the docking station via Wi-Fi, also includes a charging station. Users may use the system with only a chairside video monitor, or may connect it to a PC. The camera/handpiece includes illumination via eight white-light LEDs.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Intraoral or extraoral anatomy, oral cavity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Chairside use by dentists and dental sub-specialists, health professionals
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)
Bench top performance testing of the Kodak 1500 was performed on Hardware sub-systems, Software sub-systems, and on the complete assembled device. The system also has undergone laboratory testing for mechanical, electrical, and EMC/EMI.
Results of testing demonstrate that the device is safe and effective in meeting user requirements in accordance with its 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
§ 872.6640 Dental operative unit and accessories.
(a)
Identification. A dental operative unit and accessories is an AC-powered device that is intended to supply power to and serve as a base for other dental devices, such as a dental handpiece, a dental operating light, an air or water syringe unit, and oral cavity evacuator, a suction operative unit, and other dental devices and accessories. The device may be attached to a dental chair.(b)
Classification. Class I (general controls). Except for dental operative unit, accessories are exempt from premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.
0
Kodak 1500 Intraoral Camera
Carestream Health, Inc.
510(k) Summary Kodak 1500 Intraoral Camera
1. Company Identification
Carestream Health, Inc. 150 Verona Street Rochester, NY 14608 Establishment Registration: 1315356
2. Contact Person
Daniel Hoefer Manager, Regulatory Affairs. Dental Systems 1765 The Exchange Atlanta, GA 30339 Tel 770 226 3287 Fax 770 850 5011
3. Device Name
Commercial name: Common name: Classification name: Kodak 1500 Intraoral Camera Dental Intraoral Camera Dental Operative Unit
4. Device Classification
Class: I Product Code: EIA
5. Intended Use
The Kodak 1500 Intraoral Camera (Kodak 1500) is intended for chairside use by dentists and dental sub-specialists during oral health examinations. It provides magnified digital color images of intraoral or extraoral anatomy via a video monitor or Personal Computer (PC). Both still and video images can be captured and stored. The device allows practitioners to view the interior of the oral cavity and assist in the assessment of the overall oral health of the patient. The Kodak 1500 also provides a tool for communicating treatment requirements or results by allowing practitioner and patient to view areas of concern together, before and after procedures.
6. Device Description
The Kodak 1500 includes a camera/handpiece assembly, docking station, and embedded acquisition software. It is available in two versions: Kodak 1500 Intraoral Camera – wired and Kodak 1500 Intraoral Camera – wireless. The wireless version, in which the handpiece transmits the acquired image data to the docking station via Wi-Fi, also includes a charging station. Users may use the
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AUG 1 8 2009
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system with only a chairside video monitor, or may connect it to a PC. The camera/handpiece includes illumination via eight white-light LEDs.
7. Substantial Equivalence
The Kodak 1500 Intraoral Camera is substantially equivalent to Gendex AcuCam Concept IV Intraoral Camera System (Gendex, K000112) and to the STV Pro 2 (Trophy Radiologie, K033419).
- Each device is intended for use in dental or dental sub-specialty intraoral e video image acquisition, for the purposes of viewing the oral cavity and patient communication.
- The technological characteristics and principles of operation are � equivalent. Each device consists of a digital video camera assembled within a handpiece, connection to a docking station, and display on a chairside monitor.
- . The intended users of each device are the same or similar. Each is intended for use by dentists and other oral health specialists.
- The devices are substantially equivalent in terms of energy used or . delivered, materials, biocompatibility, labeling, workflow, technology, and other relevant characteristics.
8. Non-clinical Testing
Bench top performance testing of the Kodak 1500 was performed on Hardware sub-systems, Software sub-systems, and on the complete assembled device. The system also has undergone laboratory testing for mechanical, electrical, and EMC/EMI.
Results of testing demonstrate that the device is safe and effective in meeting user requirements in accordance with its intended use.
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Image /page/2/Picture/0 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains the department's logo in the center. The logo consists of a stylized caduceus, which is a symbol of medicine and health. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Carestream Health, Incorporated C/O Mr. Daniel Hoefer Manager, Regulatory Affairs, Dental Systems Group PracticeWorks Systems, LLC 1765 The Exchange Atlanta, Georgia 30339
AUG 1 8 2009
Re: K091186
Trade/Device Name: Kodak 1500 Intraoral Camera Regulation Number: 21 CFR 872.6640 Regulation Name: Dental Operative Unit and Accessories Regulatory Class: I Product Codes: EIA Dated: July 31, 2009 Received: August 18, 2009
Dear Mr. Hoefer:
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.
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Page 2 - Mr. Hoefer
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820): and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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/cdrh/industry/support/index.html.
Sincerely yours.
Susan Tanner
Susan Runner, D.D.S., M.A. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known): K091186
Device Name: Indications for Use:
The Kodak 1500 Intraoral Camera is indicated for use by health professionals in viewing and capturing intraoral or extraoral color video images for the purposes of:
-
Allowing practitioners to view and magnify regions of the oral cavity
-
Assisting communications with the patient by providing a view of treatment areas before and after a procedure
-
Providing images for documentation in patient records.
Prescription Use X (21 CFR Part 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR Part 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kein Ruby for NSA
(Division Sign-Off) Division of Anestheslology, General Hospital Infection Control, Dental Devices
510(k) Number:
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