(38 days)
K#013955, K#930338, 973642, and 001439
Not Found
No
The description of the "auto exposure" feature is based on a simple feedback loop measuring accumulated x-radiation, not complex AI/ML algorithms. There are no mentions of AI, ML, or related concepts in the document.
No
The device is used for radiographic examination and diagnosis, not for treating any condition.
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 by exposing an X-ray image receptor to ionizing radiation." The term "diagnosis" clearly indicates its role as a diagnostic device.
No
The device description clearly states it is an "extraoral source X-ray unit" and describes hardware components like an X-ray image receptor, sensor, and cassette, indicating it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples such as blood, urine, or tissue taken from the human body to detect diseases, conditions, or infections.
- Device Function: The Veraviewepocs Panoramic X-ray Unit with Cephalometric Capability is an imaging device that uses X-rays to create images of the patient's internal structures (teeth, jaw, skull, etc.). It does not analyze biological samples.
- Intended Use: The intended use is for "dental radiographic examination and diagnosis," which involves capturing images for visual interpretation by a healthcare professional.
Therefore, this device falls under the category of medical imaging equipment, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Veraviewepocs Panoramic X-ray Unit with Cephalometric Capability that is the subject of this 510(k) 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.
The Veraviewepocs is an extraoral source X-ray unit that is used for dental radiographic examination and diagnosis of teeth, jaw, and oral structure by exposing an X-ray image receptor to ionizing radiation.
Product codes (comma separated list FDA assigned to the subject device)
EHD, EAG
Device Description
The Veraviewepocs Panoramic X-ray Unit with Cephalometric Capability is an extraoral source X-ray unit. The modified Veraviewepocs adds a cephalometric capability to the existing device. In addition to manual settings, the modified Veraviewepocs also has an "auto exposure" feature in the cephalometric mode. Exposure time is automatically adjusted depending on the patient's size, and the device is set at 80 kV and 10mA. A sensor behind the cephalometric cassette measures the amount of x-radiation, and the exposure is terminated once the accumulated x-radiation reaches a certain level. The software used in the modified Veraviewepocs has been successfully validated by Morita. The device complies with UL2601-1 and IEC 60601-1 and uses biocompatible metals and plastics on any body contacting surfaces, such as the temple stabilizers and covers, ear rods, chin rests, patient handles, and front/rear head stabilizers.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
teeth, jaw, oral structure, TM-joints, skull
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)
The modified Veraviewepocs was tested to ensure compliance with UL2601-1 and IEC 60601-1, and it complied with the applicable requirements. The modified Veraviewepocs also passed the image quality testing. The modified Veraviewepocs complies with the applicable thermal, mechanical, and electrical safety requirements of UL2601-1 and IEC 60601-1.
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.
K#013955, K#930338, 973642, and 001439
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
§ 872.1830 Cephalometer.
(a)
Identification. A cephalometer is a device used in dentistry during x-ray procedures. The device is intended to place and to hold a patient's head in a standard position during dental x-rays.(b)
Classification. Class II.
0
510(k) SUMMARY
J. Morita Manufacturing Corporation's Veraviewepocs Panoramic X-ray Unit with Cephalometric Capability
Name of Device and Name/Address of Sponsor
| Trade or Proprietary Name: Veraviewepocs Panoramic X-ray Unit with Cephalometric | |
|---|---|
| Capability | |
| Common Name: | Extraoral Source X-ray with Cephalometric Capability |
| Classification Name: | Extraoral Source X-ray System and Cephalometer |
| Product Code : | EHD (Extraoral Source X-ray System) |
| and EAG (Cephalometer) |
J. Morita USA, Inc. 9 Mason Irvine, California USA 92618 Telephone: 949-581-9600 949-581-9688 Facsimile: Contact Person: Mr. Junichi Miyata, President Date Prepared: April 18, 2002
Intended Use
The Veraviewepocs Panoramic X-ray Unit with Cephalometric Capability that is the subject of this 510(k) 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.
Technological Characteristics and Substantial Equivalence
The Veraviewepocs Panoramic X-ray Unit is an FDA-cleared extraoral source X-ray unit that it used for dental radiographic examination and diagnosis of teeth, jaw, and oral structure by exposing an X-ray image receptor to ionizing radiation (K#013955). The modified Veraviewepocs covered by this submission simply adds a cephalometric capability to the existing device.
In addition to manual settings, the modified Veraviewepocs also has an "auto exposure" feature in the cephalometric mode. Exposure time is automatically adjusted depending on the patient's size, and the device is set at 80 kV and 10mA. A sensor behind the cephalometric cassette measures the amount of x- radiation, and the exposure is terminated once the accumulated x-radiation reaches a certain level.
1
1
The modified Veraviewepocs is substantially equivalent, for purposes of the FDA *s medical device regulations, to the predicate device, Instrumentarium Corporation Imaging Division's Orthopantomograph OP100, and particularly the upgraded ORTHOCEPH OC 100 for cephalometric radiographv (K#930338, 973642, and 001439). The modified Veraviewepocs has the same general intended use. similar principles of operation, and similar technological characteristics as the previously cleared predicate device. Although there are minor difference in the characteristics of the modified Veraviewepocs and the predicate device, these differences do not raise new questions of safety or efficacy.
The software used in the modified Veraviewepocs has been successfully validated by Morita. The software validation report describes the development process for the device's software/firmware: the software change control and code revision procedures; the system and software requirements; the software handling and storage procedures; a hazard analysis; and a software/firmware certification that the company followed the above-described procedures and policies.
The modified Veraviewepocs was tested to ensure compliance with UL2601-1 and IEC 60601-1, and and it complied with the applicable requirements. The modified Veraviewepocs will be tested and will comply with the applicable requirements of 21 C.F.R. Subchapter J prior to marketing. The modified Veraviewepocs also passed the image quality testing.
The modified Veraviewepocs complies with the applicable thermal, mechanical, and electrical safety requirements of UL2601-1 and IEC 60601-1, and will comply with the applicable requirements of 21 C.F.R. Subchapter J prior to marketing.
The modified Veraviewepocs uses biocompatible metals and plastics on any body contacting surfaces, such as the temple stabilizers and covers, ear rods, chin rests, patient handles, and front/rear head stabilizers. The metals and plastics have been widely used in other medical applications in which the metal or plastic is in body contact, including oral contact.
40100525.doc
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with three lines forming its body and head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
7 2002 .IUN
J. Morita USA, Inc. % Mr. Keith A Barritt Fish & Richardson P.C. 601 Thirteenth Street N.W. WASHINGTON DC 20005 Re: K021372
Trade/Device Name: Veraviewepocs Panoramic X-Ray Unit with Cephalometric Capability Regulation Number: 21 CFR 872.1830 Regulation Name: Cephalometer Regulatory Class: II Product Code: 76 EAG Dated: April 29, 2002 Received: April 30, 2002
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. Iisting 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 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 electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
3
· This letter will allow you to begin marketing your device as described in your 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:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
U.S. Food and Drug Administration - Center for Devices and Radiological Health
Page 1 of 1
510(k) Number (if known): K021372
Device Name: Veraviewepocs Panoramic X-ray Unit with Cephalometric Capability
Indications for Use:
The Veraviewepocs is an extraoral source X-ray unit that is used for dental radiographic examination and diagnosis of teeth, jaw, and oral structure by exposing an X-ray image receptor to ionizing radiation.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Optional Format 3-10-98)
Prescription Use
David G. Lawson
510(k) Nun