Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary does not mention AI, ML, or any related terms, and the device description focuses on the hardware components of a standard X-ray system.

Therapeutic

No
The device is described as an X-ray source for producing diagnostic images, which is an imaging device used for diagnosis, not for therapeutic treatment.

Diagnostic

Yes
The device description states its intention for "diagnosis of diseases of the teeth, jaw, and oral structures."

SaMD (Software as a Medical Device)

No

The device description explicitly states it consists of hardware components like an X-ray tube, X-Ray tube assembly, and X-Ray Controller built into a hand-held device.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
REXTAR LCD Function: The REXTAR LCD is an X-ray system. It uses radiation to create images of the teeth, jaw, and oral structures within the body. It does not analyze samples taken from the body.

The description clearly states its purpose is to produce diagnostic X-ray images using intraoral image receptors, which is a form of medical imaging, not in vitro testing.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

REXTAR LCD is a portable X-ray system to be used by trained dentists and dental technicians as a mobile, extraoral x-ray source for producing diagnostic x-ray images using intraoral image receptors. It is intended for both adult and pediatric subjects.

Product codes

EHD

Device Description

The REXTAR LCD consists of an X-ray tube, X-Ray tube assembly, X-Ray Controller built into a hand held camera-like device. The REXTAR LCD is an extraoral source x-ray system with a DC-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, X-ray camera, is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.

REXTAR LCD is a portable X-ray system that has the following qualities:

High Frequency X-ray Generator (70kV-2mA Fixed)
High Quality Toshiba Tube used (Tube Focal Spot (0.4mm))
Target Angle 12°
Easy to Move
Eliminates the need for multiple X-Ray units in doctor's office
Efficient to use
Compact Size & Light Weight Design for Ultimate Portability
Long Battery Life Hundreds of images can be obtained from one time charge
Diverse Applications (Field Hospital, Emergency, Forensic Science, Operation Room)
Can use conventional film or digital sensors to obtain images
Images from digital sensors are displayed on a computer that is not included as a part of the camera for the Rextar LCD

REXTAR also has:

Compatibility with all Digital Sensors All Digital Imaging . Sensor (USB Type) existing in the world can be used for Rextar LCD unlike other products.
Easy & Simple Installation by USB Memory Stick & ODD, . Memory Cards (SD,MMC)
Samsung Ultra Q1 (UMPC) Embedded .
Wireless data transmission has Not been tested with this device . and should not be used

Operating principle is that X-ray generated by high voltage electricity into X-ray tube, which penetrates hand, tooth and jaw, and makes X-ray images on receptor (Chemical Film or Digital Sensor).

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

X-ray

Anatomical Site

teeth, jaw, and oral structures

Indicated Patient Age Range

adult and pediatric subjects

Intended User / Care Setting

trained dentists and dental technicians

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

Not Found

Key Metrics

Not Found

Predicate Device(s)

K063121, K082167

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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.

Summary

0

K122016

MAR 0 1 2013

Attachment 3

Section 5: 510(k) Summary

lan Yun

Sales Director

1. 510(k) Owner:
  Metabiomed, Inc. 110 Gibraltar Road, suite 106 Horsham, PA 19044 USA Ph: 267-282-5893 Fax: 267-282-5899 Email: metabiomed@gmail.com
1. Company Contact: Title:
1. 510(k) Preparer:

Blix Winston ACMD Consulting, LLC. 2600 Mullinix Mill Road Mt. Airy, MD 21771 USA Ph: 301-607-9185 Email: fblixwinston@aol.com

Date of Submission
Device Name and Classification:

Trade name - REXTAR LCD Common name - Portable X-Rav System Classification name - Extraoral source x-ray system

1. Predicate Devices:
  Manufacturer : Device : 510(k) Number :

July 7, 2012

Genoray Co. Ltd. PORTX-II K063121 (Decision Date -01/11/2007)

Manufacturer: Device: 510(k) number:

Digimed Corporation DIOX K082167 (Decision Date-04/08/2011)

5-1

1

7. Classifications Names & Citations:

.

:

.

21CFR 872.1800, EHD - Extraoral source x-ray system, Class 2

·

.

2

1. Compliance with performance standards
  All components to which the standard applies are certified to conform to diagnostic equipment standards, 21 CFR 1020.30 and 1020.31.

9. Device Description:

a. General:
The REXTAR LCD consists of an X-ray tube, X-Ray tube assembly, X-Ray Controller built into a hand held camera-like device.

b. Outline:

The REXTAR LCD is an extraoral source x-ray system with a DC-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, X-ray camera, is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.

c. Features:
REXTAR LCD is a portable X-ray system that has the following qualities:
· High Frequency X-ray Generator (70kV-2mA Fixed)
· High Quality Toshiba Tube used (Tube Focal Spot (0.4mm))
· Target Angle 12°
· Easy to Move
· Eliminates the need for multiple X-Ray units in doctor's office
· Efficient to use
· Compact Size & Light Weight Design for Ultimate Portability
· Long Battery Life Hundreds of images can be obtained from one time charge
· Diverse Applications (Field Hospital, Emergency, Forensic Science, Operation Room)
· Can use conventional film or digital sensors to obtain images
· Images from digital sensors are displayed on a computer that is not included as a part of the camera for the Rextar LCD

ਟ-ਤ

3

· REXTAR also has:
- Compatibility with all Digital Sensors All Digital Imaging . Sensor (USB Type) existing in the world can be used for Rextar LCD unlike other products.
- Easy & Simple Installation by USB Memory Stick & ODD, . Memory Cards (SD,MMC)
- Samsung Ultra Q1 (UMPC) Embedded .
- Wireless data transmission has Not been tested with this device . and should not be used
d. Operating principle:

Operating principle is that X-ray generated by high voltage electricity into X-ray tube, which penetrates hand, tooth and jaw, and makes X-ray images on receptor (Chemical Film or Digital Sensor).

Indications for use:

REXTAR LCD is a portable X-ray system to be used by trained dentists and dental technicians as a mobile, extraoral x-ray source for producing diagnostic xray images using intraoral image receptors. It is intended for both adult and pediatric subjects.

1. Substantial equivalence:
  The REXTAR device had been tested to demonstrate substantial equivalence with the predicate devices. A comparison of features is included below.

4

Comparison Table: REXTAR LCD and the Predicate Devices

Parameter	Rextar LCD	PORTX-II	DIOX
510(k)	Submitted for
marketing
clearance	K063121	K103600
Intended
Use	REXTAR LCD is
a portable X-ray
system to be
used by trained
dentists and
dental technicians
as a mobile,
extraoral x-ray
source for
producing
diagnostic x-ray
images using
intraoral image
receptors. It is
intended for both
adult and
pediatric subjects.	To be used by
trained dentists
and dental
technicians a
mobile,
extraoral x-ray
source for
producing
diagnostic x-ray
images using
intraoral image
receptors. It is
intended for
both adult and
pediatric
subjects.	To be used by
trained dentists
and dental
technicians as a
mobile,
extraoral x-ray
source for
producing
diagnostic x-ray
images using
intraoral image
receptors. It is
intended for
both adult and
pediatric
subjects.
Indications	X-ray system
designed to
provide images
of the patients
undergoing
dental
procedures.
Clinical uses
include Bite
wing, periapical,
occlusal and
panoramic
images.	X-ray system
designed to
provide images
of the patients
undergoing
dental
procedures.
Clinical uses
include Bite
wing, periapical,
occlusal and
panoramic
images.	X-ray system
designed to
provide images
of the patients
undergoing
dental
procedures.
Clinical uses
include Bite
wing, periapical,
occlusal and
panoramic
images.
Dentist/dental assistant
Involvement	Supervision	Supervision	Supervision
Labeling	Submitted	Original,
Cleared	Original,
Cleared
X-ray
Generator	High-Frequency	High-Frequency	High-Frequency
Tube Power	70kV /2mA	60kV /2mA	60kV /2mA
Tube Type	Stationary	Stationary	Stationary
Tube Focal
Spot	0.4mm	0.8 mm	0.8 mm
Target
Angle	12°	20 °	20°
Exposure
Time	0.01 ~ 1.3 (sec)
(43 Steps)	0.02 ~ 2.00 (sec)
(24Steps)	0.01~1.60 (sec)
(0.01 sec/ step)
Parameter
Power
Requirement	Rextar LCD
DC 11.1 V	PORTX-II
DC 22.2V	DIOX
DC 24 V
Weight (kg)	1.88	2.95	1.80
Picture
Quality	Good	Normal	Normal
Battery
Type	Rechargeable	Rechargeable	Rechargeable
Digital
Sensor	X	X	X
LCD	LCD Panel
Display (4
Digits, 0.5 Inch
Character
Height)	X	X
Chipset &
Graphics		X	X
Memory		X	X
Storage		X	X
Communication
-tions		X	X

.

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11. Standards:

The portable x-ray system, REXTAR LCD, will comply with applicable requirements of the Underwriters Laboratories Standard for Safety-UL/IEC 60601-1, IEC 60601-2-7, IEC 60601-2-28 and IEC 60601-2-32. EMC testing was conducted by (EMC Compliance Co., Ltd. in accordance with Standard EN/IEC 60601-1-2). All test results were satisfactory.

A complete list of performance standards is listed below.

6

| No. | OEN | Reference | Title of standard | Year of
ratificatio |
|-----|---------|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| 1 | IEC | IEC 60601-1 | Medical electrical equipment-Part
1: | 1990 |
| 2 | IEC | Amendment
A1 to EN
60601-1 | Medical electrical equipment-
Part 1: General requirement
for safety | 1991 |
| 3 | IEC | Amendment A2 | Medical electrical equipment-Part
1: | 1995 |
| No. | OEN | Reference | Title of standard | Year of
ratificatio |
| 4 | IEC | IEC 60601-1-2 | Medical electrical equipment-
Part 1: General requirement
for safety - 2
Collateral standard:
Electromagnetic
Compatibility - Requirements and
test. | 2001 |
| 5 | IEC | IEC 60601-1-3 | Medical electrical equipment-
Part 1: General requirement
for safety - 3
Collateral standard: General
requirements for radiation
protection in diagnostic X-ray
equipment. | 1994 |
| 6 | IEC | IEC 60601-1-4 | Medical electrical equipment-
Part 1: General requirement
for safety - 4
Collateral standard:
Programmable electrical medical
systems | 1996 |
| 7 | IEC | IEC 60601-2-7 | Medical electrical equipment-
Part 2: Particular requirements
for the safety of High-voltage
generators of diagnostic X-ray
generators | 1998 |
| | | | | |
| 8 | IEC | IEC 60601-2-28 | Medical electrical equipment-
Part 2: Particular requirements
for the safety of X-ray source
assemblies and X-ray tube
assemblies for medical
diagnosis | 1993 |
| 9 | IEC | IEC 60601-2-32 | Medical electrical equipment-
Part 2: Particular requirements
for the safety of associated
equipment of X-ray equipment | 1995 |
| 10 | Cenelec | EN 980 | Graphical symbols for use
in the labeling of medical | 2003 |
| 11 | Cenelec | EN 1041 | Information supplied by the
manufacturer with medical
devices | 1998 |
| No. | OEN | Reference | Title of standard | Year of
ratificatio |
| 12 | ISO | ISO 14971 | Medical devices - Application
of risk | 2007 |
| 13 | ISO | ISO 13485 | Medical devices. Quality
management systems.
Requirements for regulatory
purposes. | 2003 |
| 14 | FDA | 21 CFR 1020.30
and 1020.31 | Diagnostic equipment standards | N/A |

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

5-7

7

Conclusion: Based on comparison with the predicate devices and the results of testing Metabiomed believes its REXTAR LCD device is substantially equivalent to the predicate devices.

8

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/8/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged in a circular pattern around the symbol. The logo is black and white and appears to be a scanned image.

Public Health Service

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

March 1, 2013

Meta Biomed, Incorporated C/O Mr. Blix Winston ACMD Consulting, Limited Liability Company 2600 Mullinix Mill Road MOUNT AIRY MD 21771

Re: K122016

Trade/Device Name: REXTAR LCD

Regulation Number: 21 CFR 872.1800

Regulation Name: Extraoral Source X-Ray System

Regulatory Class: II

Product Code: EHD

Dated: February 7, 2013

Received: February 12, 2013

Dear Mr. Winston:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

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.

9

Page 2 - Mr. Winston

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 devicerelated 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/Reportal roblem/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 (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Image /page/9/Picture/7 description: The image shows the name "Kwame O. Ulmer" in bold, black font. The letters "FDA" are in the background, with a complex, patterned design. To the right of the name, there is the text "fc" in a smaller, regular font.

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

10

Attachment 2

Indications for Use Statement

510(k) Number (if known): K122016

Device Name: REXTAR LCD

Indications for Use:

REXTAR LCD is a portable X-ray systems to be used by trained dentists and dental technicians as a mobile, extraoral x-ray source for producing diagnostic x-ray images using intraoral image receptors. It is intended for both adult and pediatric subjects.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use:	X
(Per-21MFR S01usubpart D)
Susan Runner, DOSMA	2013.02.22
	11:44:41-0500

AND.OR Over-The-Counter Use: (21 CFR 801 Subpart C)

(Division Sign-On) (Division Sign-Off)
Division of Anesthesiology, General Hospital
Division Control Dental Devices Division of Anesules.org
Infection Control, Dental Devices - 11

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