APIXIA DIGIREX DIGITAL DENTAL REDIOGRAPHY SYSTEM

K120106 · Apixia, Inc. · MUH · May 7, 2012 · Dental

Device Facts

• Record ID: K120106
• Device Name: APIXIA DIGIREX DIGITAL DENTAL REDIOGRAPHY SYSTEM
• Applicant: Apixia, Inc.
• Product Code: MUH · Dental
• Decision Date: May 7, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.1800
• Device Class: Class 2

Intended Use

The Apixia Digital Dental Radiography System replaces the traditional film approach to x-ray imaging. Phosphor plates and a scanner are the main components of the device. The device is used to capture x-rays from an external source and produce digital dental radiographs of a patient's mouth. The digital images can be used for analysis, archiving and electronic transmission.

Device Story

System captures dental x-rays using phosphor plates; scanner processes plates to produce digital radiographs. Used in dental clinics by dental professionals. Digital output allows for image analysis, archiving, and electronic transmission. Replaces traditional film-based radiography; improves workflow efficiency through digital storage and retrieval.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

System consists of phosphor plates and a digital scanner. Operates as an extraoral source x-ray system (21 CFR 872.1800). Digital imaging output.

Indications for Use

Indicated for dental patients requiring radiographic imaging of the mouth. Replaces traditional film-based x-ray imaging.

Regulatory Classification

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.

Predicate Devices

• Apixia Digirex Digital Dental Radiography System (K112566)

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

MAY - 7 2012

Mr. Eric Huang Product Manager Apixia Inc. 18688 San Jose Avenue INDUSTRY CA 91748

Re: K120106

Trade/Device Name: Apixia Digirex Digital Dental Radiography System Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH Dated: April 17, 2012 Received: April 23, 2012

## Dear Mr. Huang:

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 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. 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 toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours,

Janine M. Morris

Janine M. Morris Acting 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 Statement

## 510(k) Number (if known): K120106

Device Name: Apixia Digirex Digital Dental Radiography System

Indications for Use:

The Apixia Digital Dental Radiography System replaces the traditional film approach to x-ray imaging. Phosphor plates and a scanner are the main components of the device. The device is used to capture x-rays from an external source and produce digital dental radiographs of a patient's mouth. The digital images can be used for analysis, archiving and electronic transmission.

Prescription Use X (Part 21 CFR 801 Subpart D)

510K

Over-the Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

AND/OR

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

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