(27 days)
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Not Found
No
The summary does not mention AI, ML, or related terms, nor does it describe features or performance metrics typically associated with AI/ML-powered devices.
No
Explanation: The device is described as a computed tomography x-ray system for diagnostic support, which means it aids in identifying diseases or conditions rather than treating them.
Yes
The "Intended Use / Indications for Use" states that the device is "for use in diagnostic support."
No
The device description explicitly states it is a "computed tomography x-ray system," which is a hardware device.
Based on the provided information, the EPX-Impla device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens taken from the human body (like blood, urine, or tissue) outside of the body. They are used to provide information about a person's health status.
- The EPX-Impla is an imaging system that uses X-rays to acquire images of the head and neck. It works by scanning the patient directly, not by analyzing samples taken from the patient.
The description clearly states it's a "computed tomography x-ray system" used for "diagnostic support" by imaging the patient's head and neck. This falls under the category of medical imaging devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
EPX-Impla is a computed tomography x-ray system that acquires a 360° rotational sequence of the head and neck areas, including the ENT and dentomaxillofacial area for use in diagnostic support.
Product codes
JAK
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
computed tomography x-ray
Anatomical Site
head and neck areas, including the ENT and dentomaxillofacial area
Indicated Patient Age Range
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Intended User / Care Setting
operated and used by physicians, dentists, and x-ray technologists.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
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Image /page/0/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract, wavy lines that resemble human figures or flowing water.
APR 5 - 2007
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
E-WOO Technology Co., Ltd. % Mr. Stephen T. Mlcoch President North American Technical Services (NATS) Corp. 30 Northport Road SOUND BEACH NY 11789
Re: K070658
Trade/Device Name: E-WOO Dental Imaging System Model EPX Impla Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: November 15, 2007 Received: March 9, 2007
Dear Mr. Mlcoch:
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.
Image /page/0/Picture/10 description: The image is a circular emblem with the text "1800-1900" at the top and "Centennial" at the bottom. The letters "PA" are prominently displayed in the center of the emblem. Three stars are arranged in a horizontal line below the word "Centennial". The emblem appears to be a commemorative seal or logo, possibly related to a centennial celebration of Pennsylvania.
Protecting and Promoting Public Health
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Page 2 -
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.
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 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.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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 (240) 276-3150
or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
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E-Woo Dental Imaging System Model EPX-Impla 510K Notification
INDICATIONS FOR USE
510(k) Number (if known):
KO706 58
Device Name:
Indications for Use:
E-Woo Dental Imaging System Model EPX-Impla
EPX-Impla is a computed tomography x-ray system that acquires a 360° rotational sequence of the head and neck areas, including the ENT and dentomaxillofacial area for use in diagnostic support. The device is operated and used by physicians, dentists, and x-ray technologists.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
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)
Page 1 of 1
Ehristha Iverson
Division Sign-Off) Division of Reproductive, Abdominal and Radiological Device
510(k) Number K070658