(246 days)
Not Found
Not Found
No
The provided 510(k) summary does not contain any mention of AI, ML, deep learning, training sets, test sets, or performance metrics typically associated with AI/ML devices. It describes a standard digital x-ray imaging system.
No
The device is described as producing images for diagnostic support, not for treatment or therapy.
Yes
The 'Intended Use / Indications for Use' section explicitly states that the system is intended to produce images "as diagnostic support".
No
The device is described as a "system" intended to produce digital x-ray images, which inherently involves hardware components for image acquisition (the x-ray machine itself). The summary does not mention it being solely software for processing or analysis of images acquired by a separate device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens obtained from the human body (like blood, urine, tissue) to provide information for diagnosis.
- This device is an imaging system that produces digital x-ray images of anatomical regions. It directly images the patient's body, rather than analyzing a sample taken from the body.
The intended use clearly describes the device as producing images for diagnostic support based on direct imaging of the patient's anatomy. This falls under the category of medical imaging devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The CS 9300 and CS 9300C are systems intended to produce two-dimensional and three-dimensional digital x-ray images of the dento-maxillo-facial, and ENT (Ear, Nose and Throat) regions at the direction of healthcare professionals as diagnostic support for pediatric and adult patients.
In addition, the CS 9300C is intended to produce cephalometric images. This includes imaging the hand and wrist to obtain the carpus image for growth and maturity assessment.
Product codes
OAS
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray
Anatomical Site
dento-maxillo-facial, and ENT (Ear, Nose and Throat) regions, hand and wrist (carpus)
Indicated Patient Age Range
pediatric and adult patients
Intended User / Care Setting
healthcare 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)
Not Found
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.
Not Found
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
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an image of an eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Mr. Marie-Pierre Labat-Camy Regulatory Affairs Manager Trophy 4, rue F. Pelloutier-Croissy-Beaubourg 77435 Marne La Vallée Cedex 2 FRANCE
AUG 1 8 2011
Re: K103659 Trade/Device Name: CS 9300 and CS 9300C Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: OAS Dated: August 15, 2011 Received: August 16, 2011
Dear Mr. 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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of
1
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office
of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours.
Mary Patel
Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
2
Traditional 510(k): CS 9300 and CS 9300C
INDICATIONS FOR USE
510 (k) Number: K103659
CS 9300 and CS 9300C Device Name:
Indications For Use:
The CS 9300 and CS 9300C are systems intended to produce two-dimensional and three-dimensional digital x-ray images of the dento-maxillo-facial, and ENT (Ear, Nose and Throat) regions at the direction of healthcare professionals as diagnostic support for pediatric and adult patients.
In addition, the CS 9300C is intended to produce cephalometric images. This includes imaging the hand and wrist to obtain the carpus image for growth and maturity assessment.
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)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K
6163659