(37 days)
Not Found
No
The summary describes a standard panoramic X-ray machine with mechanical movement and sensor technology, without mentioning any AI or ML capabilities for image processing or analysis.
No
This device is for diagnostic imaging (radiographic use) and explicitly states its purpose is for "diagnostic radiographic use," not therapeutic treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "For Panoramic or Cephalometric diagnostic radiographic use".
No
The device description clearly describes a physical X-ray machine with mechanical components (movement axes) and a sensor, indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This testing is performed outside of the living body (in vitro).
- 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 within the living body (in vivo). It does not analyze specimens taken from the patient.
- Intended Use: The intended use is for "Panoramic or Cephalometric diagnostic radiographic use," which clearly describes an imaging function, not an in vitro diagnostic test.
Therefore, based on the provided information, the device is a medical imaging device, not an In Vitro Diagnostic device.
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)
EHD, MUH
Device Description
The ENCOMPASS HF100- Eagle Panoramic X-Ray Machine is a complete system for dental imaging capable of: Film Panoramic Profiles Film Cephalometric Profiles Digital Panoramic Profiles Digital Cephalometric Profiles The digital machines use a sensor with CdTe/CMOS technology for imaging that allows for direct conversion between x-ray photons into voltage levels making it less noisy than traditional scintillator technologies. 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).
Mentions image processing
Not Found
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)
Performance testing: Accuracy testing and software validation was performed. All test results were satisfactory.
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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MAR 1 7 2011
510(k) Summary K : 110371
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date prepared: _November 15, 2010
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Company and Correspondent making the submission: Name - Panoramic Corp. Address – 4321 Goshen rd. , Fort Wayne, IN 46818 Telephone - 800-654-2027 Contact - Doug Pack
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Device :
- Trade/proprietary name : ENCOMPASS HF100- Eagle Panoramic/Cephalometric X-Ray Common Name : Dental X-rav Classification Name : Extraoral source x-ray system
3. Predicate Device:
K043307, Cranex D made by Soredex.
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- Classifications Names & Citations :
21 CFR § 872.1800, Class 2 Product code EHD
- Classifications Names & Citations :
-
- Description : The ENCOMPASS HF100- Eagle Panoramic X-Ray Machine is a complete system for dental imaging capable of: Film Panoramic Profiles Film Cephalometric Profiles Digital Panoramic Profiles Digital Cephalometric Profiles The digital machines use a sensor with CdTe/CMOS technology for imaging that allows for direct conversion between x-ray photons into voltage levels making it less noisy than traditional scintillator technologies. 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).
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- 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 Cranex D made by Soredex is a Pan/Ceph device digital image capture system. The new device ENCOMPASS HF100 Eagle is a digital capture type Pan/Ceph system. Technologies employed by the predicates and our new device are nearly identical.
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8. 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; IEC 60601-2-7/2001; 60601-2-28/2001; IEC 60601-2-32/2001. Performance testing: Accuracy testing and software validation was performed. All test results were satisfactory.
9. Conclusions :
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 is safe and effective and substantially equivalent to predicate devices as described herein.
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Image /page/2/Picture/0 description: The image shows a logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the seal is an abstract symbol of a human figure. To the right of the seal is the word "DEPART" in a bold, sans-serif font.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Panoramic Corporation % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1 394 25" Street NW BUFFALO MN 55313
MAR 1 7 201
Re: K110371
Trade/Device Name: ENCOMPASS HF100-Eagle Panoramic/Cephalometric X-Ray Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH Dated: February 7, 2011 Received: February 8, 2011
Dear Mr. Job:
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 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 500(). This stet notification. The FDA finding of substantial equivalence of your device to a logal y renable 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 (01) 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 tollying mo (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours.
Mary Statel
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
510(k) Number(if known): K1003 7 /
Device Name: ENCOMPASS HF100- Eagle Panoramic/Cephalometric X-Ray
Indications for Use:
For Panoramic or Cephalometric diagnostic radiographic use in dental, oral surgery, and orthodontic practices.
Prescription Use X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (Part 21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Mary S. Pastel
Concurrence of/CDRH, Office of In Vitro Diagnostic Devices (OIVD)
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(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510K K110321