(90 days)
Not Found
No
The description mentions "auto image processing" but provides no details suggesting the use of AI/ML algorithms. There are no mentions of AI, DNN, or ML, nor are there descriptions of training or test sets typically associated with AI/ML development.
No
The device is described as an X-ray machine for diagnostic use, not for treating any condition.
Yes
The "Intended Use / Indications for Use" section explicitly states "For diagnostic radiographic use".
No
The device description clearly states it is a "complete system for dental imaging" and includes hardware components like a "Panoramic X-Ray Machine with CCD sensor" and "three movement axes". While it mentions "auto image processing," this is part of a larger hardware system.
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 taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The ENCOMPASS HF100-Eagle Panoramic X-Ray Machine is an imaging device that uses X-rays to create images of the dental arch and spinal region. It does not perform tests on biological samples.
- Intended Use: The intended use is for "diagnostic radiographic use," which refers to using imaging to aid in diagnosis, not performing in vitro tests.
Therefore, this device falls under the category of medical imaging equipment, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
For Panoramic or Cephalometric diagnostic radiographic use in dental, oral surgery, and orthodontic practices.
Product codes (comma separated list FDA assigned to the subject device)
MUH, EHD
Device Description
The ENCOMPASS HF100-Eagle Panoramic X-Ray Machine with CCD sensor is a complete system for dental imaging capable of Digital Panoramic Profiles and Digital Cephalometric Profiles. The machines use a sensor CCD sensor technology with the traditional scintillator technologies and auto image processing that allow a speed up the diagnostic and improve the clinic workflow. The equipment has three movement axes (two in orthogonal directions and one rotational) making it possible to execute elaborate imaging profiles. It features a complex profile movement around the dental arch and radiographic emission compensation in the spinal region, when necessary reconstructing the dental arch into a plane image.
Each individual profile prioritizes a set of characteristics improving diagnostic capabilities. For example, the standard panoramic prioritizes image layer width, constant vertical magnification and homogeneous exposure along the whole image. Likewise, the low dosage profile prioritizes the reduction of dosage (time and anodic current). ONLY THE SENSOR HAS CHANGED.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-Ray
Anatomical Site
Dental arch, spinal region (for radiographic emission compensation)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Dental, oral surgery, and orthodontic practices.
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)
Clinical Summary: We had a licensed dentist review the predicate and new device pan and ceph images. He found them to have comparable diagnostic quality, sharpness, and overall quality.
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
JUL 3 0 2014
510(k) Summary Page 1 of 2.
ENCOMPASS HF100-Eagle Panoramic/Cephalometric X-Ray with CCD ser K141130
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date prepared: July 28, 2014
- Company and Correspondent making the submission:
Name - Panoramic Corp. Address - 4321 Goshen rd. , Fort Wayne, IN 46818 Telephone -- 800-654-2027 Contact - Doug Pack
- Device: Trade/proprietary name : ENCOMPASS HF100-Eagle Panoramic/Cephalometric X-Ray with CCD sensor
Common Name: Dental Panoramic/Cephalometric X-ray Classification Name: Extraoral source x-ray system
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Predicate Device: K110371, Encompass made for Panoramic Corp.
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Classifications Names & Citations: 21 CFR § 872.1800, Class 2 Product codes MUH (Primary) and EHD (Secondary)
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Description : The ENCOMPASS HF100-Eagle Panoramic X-Ray Machine with CCD sensor is a complete system for dental imaging capable of Digital Panoramic Profiles and Digital Cephalometric Profiles. The machines use a sensor CCD sensor technology with the traditional scintillator technologies and auto image processing that allow a speed up the diagnostic and improve the clinic workflow. The equipment has three movement axes (two in orthogonal directions and one rotational) making it possible to execute elaborate imaging profiles. It features a complex profile movement around the dental arch and radiographic emission compensation in the spinal region, when necessary reconstructing the dental arch into a plane image.
Each individual profile prioritizes a set of characteristics improving diagnostic capabilities. For example, the standard panoramic prioritizes image layer width, constant vertical magnification and homogeneous exposure along the whole image. Likewise, the low dosage profile prioritizes the reduction of dosage (time and anodic current). ONLY THE SENSOR HAS CHANGED.
-
Indication for use: For Panoramic or Cephalometric diagnostic radiographic use in dental, oral surgery, and orthodontic practices.
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Comparison with predicate devices: The ENCOMPASS HF100 Eagle with CdTe sensor made for Panoramic is a Pan/Ceph device digital image capture system. The new device ENCOMPASS HF100 Eagle with CCD sensor is a digital capture type Pan/Ceph system. Technologies employed by the predicates and our new device are nearly identical. The resolution figures are as good as or better than our former sensors used in our predicate K110371 .
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K141130
Page 2 of 2
510(k) Summary Page 2 of 2. ENCOMPASS HF100-Eagle Panoramic/Cephalometric X-Ray with CCD sensor K141130
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Safety, EMC, Biocompatibility (N/A) and Performance Data: Electrical, mechanical, environmental safety and performance testing according to standard IEC 60601-1 was performed, and EMC testing . was conducted in accordance with standard IEC 60601-1-2(2001). Compliance testing was performed for the applicable portions of the following X-Ray standards: IEC 60601-1-3/2001: 60601-2-28/2001; IEC 60601-2-32/2001. Performance testing: Accuracy testing and software validation was performed. All test results were satisfactory.
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Clinical Summary: We had a licensed dentist review the predicate and new device pan and ceph images. He found them to have comparable diagnostic quality, sharpness, and overall quality.
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Conclusion: In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification Panoramic Corp. concludes that the ENCOMPASS HF100-Eagle Panoramic/Cephalometric X-Ray with CCD sensor is safe and effective and substantially equivalent to predicate devices as described herein.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol featuring three horizontal lines that curve upwards, resembling a human figure.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, M1) 20993-0002
July 30, 2014
Panoramic Corporation % Daniel Kamm, P.E. Principal Consultant Kamm and Associates 8870 Ravello Court NAPLES FL 34114
K141130 રિભ: Trade/Device Name: Encompass Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source X-Ray system Regulatory Class: II Product Code: MUH. EHD Dated: April 22, 2014 Received: May 1, 2014
Dear Mr. Kamm:
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 upproval 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not mislcading.
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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
Page 2-Mr. Kamm
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (2) 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
for
Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
4
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
510(k) Number (if known)
Device Name
ENCOMPASS HF100- Eagle Panoramic/Cephalometric X-Ray
Indications for Use (Describe)
For diagnostic radiographic use in dental, oral surgery, and orthodontic practices.
Type of Use (Select one or both, as applicable)
8 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signalure)
Sm.h.7)
FORM FDA 3881 (1/14)
5
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