(60 days)
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Not Found
No
The summary does not mention AI, ML, deep learning, or any related terms, nor does it describe features or performance metrics typically associated with AI/ML-powered image analysis or processing.
No
The device is an x-ray imaging system intended to produce images for diagnostic purposes, not for treating any condition.
Yes
The device is described as an "x-ray imaging system" intended to "produce three dimensional x-ray image of the dento-maxillo-facial area." Imaging systems that produce medical images are used by healthcare professionals to diagnose conditions, making them diagnostic devices.
No
The device is described as an "Extra-oral x-ray imaging system," which inherently implies the presence of hardware components for generating and capturing x-ray images. The summary does not mention any software-only functionality.
Based on the provided information, the Kodak 9500 Extra-oral x-ray imaging system is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to produce three-dimensional x-ray images of the dento-maxillo-facial area. This involves imaging the internal structures of the body, which is characteristic of in vivo diagnostic imaging, not in vitro diagnostics.
- 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. The Kodak 9500 does not perform such tests.
- Imaging Modality: The device uses x-ray imaging, which is a common modality for in vivo diagnostic imaging.
Therefore, the Kodak 9500 is a medical imaging device used for in vivo diagnosis, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Kodak 9500 Extra-oral x-ray imaging system is intended to produce three dimensional xray image 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 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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 0 5 2008
Ms. Marie-Pierre Labat-Camy Regulatory Affairs Manager TROPHY 4 rue F. Pelloutier, Croissy-Beaubourg Marne la Vallee cedex 2, 77 435 FRANCE
Re: K082972
Trade/Device Name: Kodak 9500 Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH Dated: September 26, 2008 Received: October 7, 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 (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.
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.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (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 Biometrics' (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/cdrh/industry/support/index.html.
Sincerely vours.
hoque An Whang
Joyce M. Whang, Ph.D. Acting Director. Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
510 (k) Number : K082972
Device Name : Kodak 9500
Indications For Use :
Kodak 9500 Extra-oral x-ray imaging system is intended to produce three dimensional xray image 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 )
( Please do not write below this line - Continue on another page if needed )
Concurence of CDRH, Office of Device Evaluation (ODE)
Helal Remen
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number