(260 days)
The NAOMI-DPX D100 is indicated for use in acquiring Panoramic radiographic images at the dento-maxillofacial region. The image generated is displayed on a computer monitor. It is intended to replace radiographic film/screen system in dental diagnostic procedures
The NAOMI-DPX-D100 provided digital image capture for conventional film/screen systems. It is intended to replace the radiographic film/screen systems.
The x-ray photons incident to the NAOMI-DPX-D100 are detected and converted into the light photons at the scintillator. The light photons are detected and converted into the electrical signal at the CCD. NAOMI-DPX software captures and displays the image.
The provided text does not contain information about acceptance criteria and a study proving the device meets those criteria. The document is a 510(k) summary for a Digital X-Ray Imaging System (NAOMI-DPX-D100), primarily focusing on its general information, device description, indications for use, and a comparison to predicate devices to establish substantial equivalence.
Specifically, the document states:
- Comparison to predicate: "The performance data demonstrate that NAOMI-DPX-D100 is as safe and effective as the predicate devices (CDR-PAN MODEL4700, Signet DXIS and DIGIPAN DPI)."
- Conclusion: "It is opinion of RF Co.,Ltd. strongly believe that the NAOMI-DPX-D100 described in this submission is substantially equivalence to predicate device (NAOMI)."
This indicates that the device's performance was compared to predicate devices for substantial equivalence, but it does not detail specific acceptance criteria, the study design, or the results that would allow for filling out the requested table and answering the subsequent questions. The document mainly highlights that the device is intended to replace conventional film/screen systems and its specifications are "the same or better than NAOMI" (a previous version from the same manufacturer).
Therefore, I cannot provide the requested information.
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Section 5: 510(k) Summary
JAN - 5 2012
510(K) Summary
General Information:
| Data: | April 19, 2011 |
|---|---|
| Applicant: | RF Co., Ltd. |
| 3 Nakagosho, Nagano-shi, Nagano, 380-0935, JAPAN | |
| Contact Person: | Daisuke Tanaka |
| Telephone: | 81-26-225-7744 |
| Fax: | 81-26-225-7747 |
Proposed Device:
| Trade Name: | RF System lab. |
|---|---|
| Device Name: | Digital X-Ray Imaging System, NAOMI-DPX-D100 |
| Classification Name: | 90MQB, Solid State X-ray imager |
Predicate Device:
| RF System.lab. : | NAOMI (K062376) |
|---|---|
| Schick Technologies, Inc. : | CDR-PAN MODEL 4700 (K982661) |
| Signet Radiology, Inc. : | Signet DXIS (K983283) |
| Trophy Radiologie : | DIGIPAN / DPI (K012514) |
· Device Description:
The NAOMI-DPX-D100 provided digital image capture for conventional film/screen systems. It is intended to replace the radiographic film/screen systems.
The x-ray photons incident to the NAOMI-DPX-D100 are detected and converted into the light photons at the scintillator. The light photons are detected and converted into the electrical signal at the CCD. NAOMI-DPX software captures and displays the image.
Indications for Use:
The NAOMI-DPX-D100 provides digital image capture for conventional film/screen radiographic examinations. The device is intended to replace the radiographic film/screen systems in panoramic dental diagnostic procedures.
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Section 5: 510(k) Summary
Comparison to predicate:
The use of the NAOMI-DPX-D100 is the same as predicate devices. The value that evaluate image quality is different from NAOMI, however, most of the specifications are the same or better than NAOMI.
Conclusion:
l
The performance data demonstrate that NAOMI-DPX-D100 is as safe and effective as the predicate devices (CDR-PAN MODEL4700, Signet DXIS and DIGIPAN DPI). It is opinion of RF Co.,Ltd. strongly believe that the NAOMI-DPX-D100 described in this submission is substantially equivalence to predicate device (NAOMI).
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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The logo consists of a stylized graphic of a person in blue, along with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in blue. The text is in all caps and is to the right of the graphic.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Mr. Koji Kubo Manager RF CO., Ltd. 6-5-3 Beaune Homkomagome 2F HOMKOMAGOME BUNK YO-KU TOKYO 113-0021 JAPAN
AUG 2 3 2013
Re: K111103
Trade/Device Name: Digital X-Ray Imaging System. NAOMI-DPX-D100 Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH, EHD, and MQB Dated: December 7. 2011 Received: December 8, 2011
Dear Mr. Kubo:
This letter corrects our substantially equivalent letter of January 5, 2012.
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. Iisting 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
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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,
Janine M. Morris
Acting 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
510(K) Number (if known): K111103
Digital X-Ray Imaging System, NAOMI-DPX-D100 Device Name:
Indications for Use:
The NAOMI-DPX D100 is indicated for use in acquiring Panoramic radiographic images at the dento-maxillofacial region. The image generated is displayed on a computer monitor. It is intended to replace radiographic film/screen system in dental diagnostic procedures
Prescription Use X (Part 21 CFR 801 Subpart D) OR
Over-The-Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHERT PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation(ODE)
Mary S. Patil
Division Sign-Off!
Division of Radiological Devices
Office In Vitro Diagnostic Device Evaluation and Safety
K11103
510K
Page 1 of 1
§ 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.