(102 days)
Not Found
No
The description focuses on standard digital radiography technology (computed radiography with phosphor plates) and RFID for plate recognition. There is no mention of AI/ML for image analysis, diagnosis, or any other function.
No
The device is described as a "digital intraoral dental radiographic imaging system" that "captures, displays and stores diagnostic intraoral radiographic images." Its purpose is for imaging, not for treating any condition or disease.
Yes
The "Intended Use / Indications for Use" section explicitly states that "The system captures, displays and stores diagnostic intraoral radiographic images." and "The CS 7600 is indicated for use in dental digital radiography using imaging plates (phosphor storage screens) for dental intra-oral x-ray imaging." displaying diagnostic images makes this a diagnostic device.
No
The device description explicitly states that the system consists of a scanner, re-usable imaging plates, and an optional Scan & Go device, in addition to the acquisition software. This indicates the presence of significant hardware components.
Based on the provided text, the CS 7600 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens taken from the human body. The CS 7600 is a dental radiographic imaging system that captures images of the inside of the mouth using X-rays. It does not analyze biological samples like blood, urine, or tissue.
- The intended use and device description clearly state its purpose is for dental intraoral radiographic imaging. This involves capturing images of teeth, bones, and other structures within the mouth, not analyzing biological specimens.
The device is a medical imaging system used for diagnostic purposes, but it falls under the category of radiological imaging devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The CS 7600 is a digital intraoral dental radiographic imaging system intended for use by dentists and dental sub-specialists. The system captures, displays and stores diagnostic intraoral radiographic images. It consists of a scanner, re-usable imaging plates, acquisition software, disposable hygienic barrier envelopes, and optional Scan & Go device.
The CS 7600 is indicated for use in dental digital radiography using imaging plates (phosphor storage screens) for dental intra-oral x-ray imaging.
Product codes (comma separated list FDA assigned to the subject device)
MUH
Device Description
The CS 7600 is a computed radiography system for dental intraoral applications. Imaging plates (i.e., storage phosphor plates) are exposed in the same way as traditional x-ray film. The x-ray images on these plates are then fed into a small computed radiography system and scanned using a laser. The scanned image data from the plates is digitized, and the images are displayed on a monitor and saved to computer.
The CS 7600 system is capable of scanning the X-ray exposed imaging plates at various speeds, sizes and resolutions. Once an imaging plate is scanned, the image data is automatically erased from the plate and the plate ejected for reuse.
Re-usable intraoral imaging plates of sizes 0, 1, 2, 3 and 4 are included with the device, as are disposable hygienic barrier sheaths. The system includes an optional Scan and Go system, which uses RFID technology to automatically recognize imaging plates as they are scanned.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray
Anatomical Site
intraoral
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dentists and dental sub-specialists
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 of the CS 7600 was performed on software, hardware systems, media, and on the complete assembled device. The RFID technology has been tested for compliance with FCC and international rules for low power transmitters.
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.)
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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.
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
§ 872.1800 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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510(k) Summary CS 7600
SEP 2 3 2011
1. Company Identification
Carestream Health, Inc. 150 Verona Street Rochester. NY 14608 Establishment Registration: 1315356
2. Contact Person
Daniel Hoefer Manager, Regulatory Affairs, Carestream Dental 1765 The Exchange Atlanta, GA 30339 Tel 770 226 3287 Fax 770 850 5011
3. Device Name
Commercial name: Common name: Classification name:
CS 7600 Dental Computed Radiography System Extraoral source x-ray system
4. Device Classification
Class: II, 21 CFR 872.1800 Product Code: MUH
5. Intended Use
The CS 7600 is a digital intraoral dental radiographic imaging system intended for use by dentists and dental sub-specialists. The system captures, displays and stores diagnostic intraoral radiographic images. It consists of a scanner, re-usable imaging plates, acquisition software, disposable hygienic barrier envelopes, and optional Scan & Go device.
6. Device Description
The CS 7600 is a computed radiography system for dental intraoral applications. Imaging plates (i.e., storage phosphor plates) are exposed in the same way as traditional x-ray film. The x-ray images on these plates are then fed into a small computed radiography system and scanned using a laser. The scanned image data from the plates is digitized, and the images are displayed on a monitor and saved to computer.
The CS 7600 system is capable of scanning the X-ray exposed imaging plates at various speeds, sizes and resolutions. Once an imaging plate is scanned, the image data is automatically erased from the plate and the plate ejected for reuse.
1
Re-usable intraoral imaging plates of sizes 0, 1, 2, 3 and 4 are included with the device, as are disposable hygienic barrier sheaths. The system includes an optional Scan and Go system, which uses RFID technology to automatically recognize imaging plates as they are scanned.
7. Substantial Equivalence
The CS 7600 is substantially equivalent the Kodak CR 7400 (K060079) and the Soredex Digora Optime (K041050). Each listed device is a computed radiography device utilizing phosphor plates for dental diagnostic imaging. The devices are equivalent in terms of indications for use, operating principle and technology, energy used, and materials.
8. Non-Clinical testing
Verification and validation testing of the CS 7600 was performed on software, hardware systems, media, and on the complete assembled device. The RFID technology has been tested for compliance with FCC and international rules for low power transmitters.
Results of testing demonstrate that the device is safe and effective in meeting user requirements in accordance with its intended use.
9. Conclusion
The CS 7600 is substantially equivalent to the predicate devices listed above. Testing has demonstrated that it is safe and effective for its intended use.
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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a stylized depiction of an eagle or bird with three wing-like lines, representing health and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -- WO66-G609 Silver Spring, MD 20993-0002
Mr. Daniel Hoefer Manager. Regulatory Affairs Carestream Health, Inc. 1765 The Exchange, Inc. ATLANTA GA 30339
Regulatorv Class: H Product Code: MUH Dated: September 8, 2011 Received: September 9, 2011
Trade/Device Name: CS 7600
Regulation Number: 21 CFR 872.1800
Regulation Name: Extraoral source x-ray svstem
Re: K111649
SEP 2 3 2011
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. Ilisting 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
3
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 Viro 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.hunl.
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
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Indications for Use
The CS 7600 is indicated for use in dental digital radiography using imaging plates (phosphor storage screens) for dental intra-oral x-ray imaging.
Concurrence of CDRH, Office of Device Evaluation
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter
Michael D'Her
(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510K K///649