(50 days)
K#030699, K#030699
No
The document describes a dental panoramic x-ray system with automatic exposure control using a CCD sensor and digital image processing. There is no mention of AI, ML, or related concepts like training or test sets.
No.
The device is used for examination and diagnosis (diagnostic imaging), not for treatment or therapy.
Yes
The 'Intended Use / Indications for Use' section explicitly states that the device is "used for dental radiographic examination and diagnosis of teeth, jaw, oral structure, TM-joints and skull". The 'Device Description' also reiterates that it is "intended to produce x-rays for dental radiographic examination and diagnosis of disease of the teeth, jaw and oral structure". These statements confirm its role in diagnosis.
No
The device description explicitly states it is an "extraoral source x-ray unit" and a "dental panoramic x-ray system," indicating it is a hardware device that produces X-rays. While it mentions digital processing with a CCD sensor, this is part of the hardware system for image acquisition.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- 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.
- Device Function: The Veraview IC 5 (XDP1) is an extraoral source x-ray unit. Its function is to generate X-rays to create images of the internal structures of the teeth, jaw, and skull. This is an imaging device, not a diagnostic test performed on a biological sample.
- Intended Use: The intended use is for "dental radiographic examination and diagnosis," which involves interpreting images, not analyzing biological samples.
The device is clearly described as an X-ray system used for imaging, which falls under the category of medical imaging devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Veraview IC 5 (XDP1) is an extraoral source x-ray unit that is used for dental radiographic examination and diagnosis of teeth, jaw, oral structure, TM-joints and skull by exposing an X-ray image receptor to ionizing radiation.
Product codes (comma separated list FDA assigned to the subject device)
MUH
Device Description
The Veraview IC5 Model XDP1( hercinafter XDP1) is an extragral source dental panoramic x-ray system intended to produce x-rays for dental radiographic examination and diagnosis of disease of the teeth, jaw and oral structure.
The XDP Ican be used to take standard panoramic images, Pedodontic panoramic images, and TMJ quadruple images.
This XDP1 is a device modified from the X550P-D-UL which is one of Veraview epocs Model VE ( K#030699) of J.MORITA MFG. CORP. Both XDP1and X550P-D-UL are dental panoramic device, XDP1 is provided with automatic exposure control by CCD sensor while the latter is incapable of such automatic exposure control.
Except automatic exposure control, the main hardware is used unchanged in the same way as the previous, and the XDP1 reserves the same general intended use, similar principles of operation, and similar technological characteristics as the previously cleared predicate device, so that the XDP1 is substantially equivalent to Veraviewepocs Model VE ( K#030699).
Mentions image processing
The XDPI is used with the purpose to obtain dental x-ray panoramic tomography pictures by digital processing with a CCD sensor which is capable of electronic imaging over the whole Dento-maxillofacial area such as teeth, periodontal tissues or chin- bone etc.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
teeth, jaw, oral structure, TM-joints and skull, Dento-maxillofacial area such as teeth, periodontal tissues or chin- bone
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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.
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.
0
JAN 6 2006
510(k) SUMMARY J. Morita USA Inc.'s Veraview IC 5 XDP1
1. Submitter Name and Address with Phone/Fax :
Registration No. 2081055 Registration No. 3002807636 Initial Distributor: Manufacturer: J. Morita USA, Inc. J. MORITA MFG. CORP. 9 Mason 680 Higashihama Minami-cho Irvine, CA 92618 Fushimi-ku, Kyoto USA Japan 612-8533 949-581-9600 Telephone: +81-75-611-2141 Facsimile: 949-581-9688 +81-75-605-2354
2. Contact Person
- Keith A. Barritt Fish & Richardson P.C. 1425 K Street, N.W. Suite 1100 Washington, DC 20005 Phone: (202) 783-5070 Facsimile: (202) 783-2331
3. Date summary prepared: October 17, 2005
4. Device Name:
| Trade or Proprietary Name: | Veraview IC 5 Model XDP1 |
|---|---|
| Common Name: | Dental Panoramic X-ray Unit |
| Classification Name: | Extraoral Source dental X-ray System |
| (21CFR872.1800) | |
| Product Code : | MUH |
-
- Substantial Equivalency is claimed against the following device: Veraviewepoes Model VE from J. MORITA MFG.CORP.
510k # : K030699
- Substantial Equivalency is claimed against the following device: Veraviewepoes Model VE from J. MORITA MFG.CORP.
1
6. Description of the device:
The Veraview IC5 Model XDP1( hercinafter XDP1) is an extragral source dental panoramic x-ray system intended to produce x-rays for dental radiographic examination and diagnosis of disease of the teeth, jaw and oral structure.
The XDP Ican be used to take standard panoramic images, Pedodontic panoramic images, and TMJ quadruple images.
This XDP1 is a device modified from the X550P-D-UL which is one of Veraview epocs Model VE ( K#030699) of J.MORITA MFG. CORP. Both XDP1and X550P-D-UL are dental panoramic device, XDP1 is provided with automatic exposure control by CCD sensor while the latter is incapable of such automatic exposure control.
Except automatic exposure control, the main hardware is used unchanged in the same way as the previous, and the XDP1 reserves the same general intended use, similar principles of operation, and similar technological characteristics as the previously cleared predicate device, so that the XDP1 is substantially equivalent to Veraviewepocs Model VE ( K#030699).
7. Intended Use
The XDPI is used with the purpose to obtain dental x-ray panoramic tomography pictures by digital processing with a CCD sensor which is capable of electronic imaging over the whole Dento-maxillofacial area such as teeth, periodontal tissues or chin- bone etc.
8. Safety and effectiveness of the device
This Model XDPI is a modified device from the Veraviewepoes Model VE ( K#030699) of J.MORITA MFG. CORP. by climinating the film image receptor to CCD sensor. However, not only the main hardware is used unchanged in the same way as the predicate device, but also the XDP1 reserves the same general intended use, similar principles of operation, and similar technological characteristics, so that the XDP is substantially equivalent to the Veraviewepoes Model VE ( K#030699).
Although there are minor differences in the characteristics between the Model XDP I and the predicate device as is shown at Table-1 and Table-2, these differences do not raise new questions of safety or effectiveness because they are able to be considered as almost same .
2
| This new submission | Predicate | Difference | |
|---|---|---|---|
| Name of the model | XDP1 | X550P-D-UL | Different |
| Manufacturer | J.MORITA MFD. CORP. | J.MORITA MFD. CORP. | Identical |
| Construction | Rotating arm and base | Rotating arm and base | Similar |
| Image Receptor | X-ray CCD sensor | X-ray film and X-ray CCD sensor | Different |
| Performance spec. | International standards | International standards | Similar |
| Mechanical | XDP1 mechanism | X550P mechanism | Similar |
| Electrical | XDP1 electric circuit | X550P electric circuit | Similar |
| Software | XDP1software | X550P software | Different |
| Testing | VDE | VDE | Similar |
Table-1 Comparison summary chart
Table-2 Comparison summary table
FDA file reference number 510k number ; K030699
Attachment inside notification submission file 510k FDA website print out
| Model name of Predicate Device | X550P-D-UL |
|---|---|
| 510(k) number of Predicate Device | K030699 |
| TECHNOLOGICAL CHARACTERISTICS | Comparison result |
| Indication for use | Identical |
| Target population | Identical |
| Design | Similar |
| Materials | Similar |
| Performance | Similar |
| Sterility | Similar |
| Biocompatibility | Similar |
| Mechanical safety | Similar |
| Chemical safety | Identical |
| Anatomical sites | Similar |
| Human factors | Similar |
| Energy used and/or delivered | Similar |
| Compatibility with environment and other devices | Similar |
| Where used | Identical |
| Standards met | Identical |
| Electrical safety | Similar |
| Thermal safety | Identical |
| Radiation safety | Identical |
3
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 6 2006
2006
J. Morita USA, Inc. c/o Mr. Keith A. Barritt Attorney Fish & Richardson P.C. 1425 K Street, N.W., Suite 1100 WASHINGTON DC 20005
Re: K053220 Trade/Device Name: Veraview IC 5(XDP1)
Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system
Regulatory Class: II Product Code: MUH Dated: November 15, 2005 Received: November 17, 2005
Dear Mr. Barritt:
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 (Premarket Approval), 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.
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 (QS) regulation (21 CFR Part 820); and if applicable, the clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Image /page/3/Picture/13 description: The image shows a logo with a circular border containing text. Inside the circle is a stylized drawing of an eagle or similar bird, depicted with three curved lines representing its body and wings. The text around the border appears to be part of the organization's name, but it is difficult to read due to the image quality and orientation.
4
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 (o 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.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Nancy C. brigdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
to known 510(k) Number (if known):
XDP1 Device Name:
Indications For Use:
The Veraview IC 5 (XDP1) is an extraoral source x-ray unit that is used for dental radiographic examination and diagnosis of teeth, jaw, oral structure, TM-joints and skull by exposing an X-ray image receptor to ionizing radiation.
Prescription Use (Part 21 CFR 801 Subpart D)
ANDIOR
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 Device Evaluation (ODE)
David A. Lyman
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
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