K Number

Device Name

PHOT-X IIS MODEL 505

Manufacturer

TAKARA BELMONT CORPORATION

Date Cleared

2014-09-03

(107 days)

Product Code

EHD

Regulation Number

872.1800

Intended Use

PHOT-X IIs Model 505 is a extraoral source dental radiographic x-ray unit. This unit works as a diagnostic purpose x-ray source for human teeth with the resultant image recorded on intraoral dental x-ray film or image receptor.

Device Description

PHOT-X IIs Model 505 dental x-ray contains; x-ray generating tubehead, control box and supporting device. Package includes Operator's Manual, Installation Manual and Warranty.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K042260,K043092,K083344

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard dental x-ray unit and does not mention any AI/ML capabilities, image processing, or performance studies related to algorithmic analysis.

Therapeutic

No
The device is described as an "x-ray unit" that is "for diagnostic purpose," which indicates it is used for imaging and not for treatment.

Diagnostic

Yes
The "Intended Use / Indications for Use" states that the unit works as a "diagnostic purpose x-ray source for human teeth".

SaMD (Software as a Medical Device)

The device description explicitly states it contains hardware components such as an "x-ray generating tubehead, control box and supporting device."

IVD (In Vitro Diagnostic)

Based on the provided information, 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, tissue) to provide information about a person's health.
Device Function: The PHOT-X IIs Model 505 is an extraoral source dental radiographic x-ray unit. Its function is to generate x-rays that pass through the patient's teeth to create an image on film or a digital receptor.
No Specimen Analysis: This device does not analyze any specimens taken from the body. It directly interacts with the patient's body (teeth) to produce an image.

Therefore, it falls under the category of a radiological diagnostic device, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The PHOT-XIIs MODEL 505 is an extraoral source dental radiographic x-ray unit. This unit works as a diagnostic purpose x-ray source for human teeth with the resultant image recorded on intraoral dental x-ray film or image receptor.

Product codes (comma separated list FDA assigned to the subject device)

EHD

Device Description

PHOT-X IIs Model 505 dental x-ray contains; x-ray generating tubehead, control box and supporting device. Package includes Operator's Manual, Installation Manual and Warranty.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

X-ray

Anatomical Site

human teeth

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

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)

Not Found

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.

Belmont, PHOT-X II Model 303 (K042260), Progeny, PREVA (K043092), Sirona, HELIODENT PLUS (K083344)

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

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

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, representing medicine and healing. The symbol is placed to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the symbol. The logo is simple and professional, reflecting the department's role in public health and human services.

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

September 3, 2014

Takara Belmont Corporation % Robert Schiff, Ph. D. President Schiff & Company, Inc. 1120 Bloomfiled Ave. WEST CALDWELL, NJ 07006

Re: K141293

Trade/Device Name: PHOT-X IIs Model 505 Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral Source X-Ray System Regulatory Class: II Product Code: EHD Dated: August 1. 2014 Received: August 4, 2014

Dear Dr. Schiff:

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.

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.

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" (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 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,

Smh.f)

for

Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

Indications for Use

510(k) Number (if known) K141293

Device Name

PHOT-X IIs Model 505

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

2 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) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

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510(k) Summary (as required by 807.92)

(1) SUBMITTER : Takara Belmont Corporation

Address : 1-1-2 Chome, Higashi-Shinsaibashi, Chuo-ku Telephone : 81-6-6213-5945 Contact person : Toshinori Kiyomatsu Date prepared : April 18, 2014

(2) DEVICE NAME : PHOT-X IIs Model 505 Trade Name : PHOT-X IIs Model 505 Common Name : Dental Periapical X-ray Classification Name : UNIT, X-RAY, EXTRAORAL WITH TIMER (per 21CFR section 872.1800, Product Code EHD)

(3) PREDICATE DEVICE : Substantial equivalence is based on following legally marketed devices. Belmont, PHOT-X II Model 303 (K042260) Progeny, PREVA (K043092) Sirona, HELIODENT PLUS (K083344)
(4) DESCRIPTION OF THE DEVICE : PHOT-X IIs Model 505 dental x-ray contains; x-ray generating tubehead, control box and supporting device. Package includes Operator's Manual, Installation Manual and Warranty.
(5) INTENDED USE : The PHOT-XIIs MODEL 505 is an extraoral source dental radiographic x-ray unit. This unit works as a diagnostic purpose x-ray source for human teeth with the resultant image recorded on intraoral dental x-ray film or image receptor.
(6) COMPARISON WITH PREDICATE DEVICES : Following table is a comparison of our new PHOT-X Ils Model 505 x-ray and predicate devices.

	New Device	Predicate Device
	BELMONT
PHOT-XIIs Model 505	BELMONT
PHOT-XII Model 303
(K042260)	Progeny
Preva
(K043092)	Sirona
HELIODENT PLUS
(K083344)
Indications for Use	The PHOT-XIIs MODEL
505 is an extraoral
source dental
radiographic x-ray
unit. This unit
works as a
diagnostic purpose
x-ray source for
human teeth with
the resultant image
recorded on
intraoral dental
x-ray film or image
receptor.	PHOT-X II MODEL 303
is a extraoral
source dental
radiographic x-ray
unit. This unit
works
as a diagnostic
purpose x-ray
source for human
teeth with the
resultant image
recorded on
intraoral dental
x-ray film or image
receptor. The
design, function
and positioning of
the x-ray
unit is similar to
most all other x-ray
machines
manufactured for
this specific
purpose over the
past thirty years.	The intended use of
the Progeny PREVA
Extra-Oral X-Ray
system is to act as
a diagnostic source
for radiographic
dental imaging:	The HELIODENT Plus
is an extraoral
X-Ray source System
intended to be used
for dental
radiographic
examination and
diagnosis of
diseases of the
teeth, jaw, and
oral structures.
A. X-ray Wave Form	DC Constant
potential	DC Constant
potential	DC Constant
potential	DC Constant
potential
	New Device	Predicate Device
	BELMONT
PHOT-XIIs Model 505	BELMONT
PHOT-XII Model 303
(K042260)	Progeny
Preva
(K043092)	Sirona
HELIODENT PLUS
(K083344)
B. Filament	Pre-heating System	Pre-heating System	Pre-heating System	Pre-heating System
C. Focal Point Measurement	0.4 mm	0.7 mm	0.4 mm	0.4 mm
D. Rated tube potential	60 or 70 kV	60 or 70 kV	60, 65 or 70 kV	60 or 70 kV
E. Rated tube current	3 or 6 mA	4 or 7 mA	4, 5, 6 or 7 mA	7 mA
F. Maximum rated tube potential	70 kV	70 kV	70 kV	70 kV
G. Rated line voltage	120 VAC	120 VAC	120 VAC	120 VAC
H. Line voltage range	108 VAC-132 VAC	108 VAC-132 VAC	108 VAC-132 VAC	108 VAC-132 VAC
I. Apparent resistance of supply mains	0.52 Ω	0.48 Ω	0.4 Ω	0.3 Ω
J. Rated line current	10 A at 70kV, 6 mA	10.8A at 70 kV, 7 mA	10 A	10 A at 70 kV, 7 mA
K. Maximum line current	11A at 70kV, 6 mA	12A at 70kV, 7 mA	Unknown	Unknown
L. Exposure time	0.01-2.0 sec.,
37 steps	0.01-3.2 sec.,
23 steps	0.01-2.0 sec	0.01-3.2 sec.,
23 steps
M. Timer accuracy	±5 msec.
(below 0.1 sec.
setting)
±10 msec.
(0.1 sec. setting &
up)	±5 msec.
(below 0.1 sec.
setting)
±10 msec.
(0.1 sec. setting &
up)	5 % ±1 msec	±10 % + 1 msec
N. Inherent filtration	1.7 mmAl Equivalent	1.7 mmAl Equivalent	Unknown	Unknown
O. Added filtration	0.3 mmAl	0.3 mmAl	Unknown	Unknown
P. Minimum filtration permanently in useful beam.	2.0 mmAl Equivalent
at 70 kV	2.0 mmAl Equivalent
at 70 kV	2.0 mmAl Equivalent
at 70 kV	Unknown
Q. Nominal roentgen output
1-Distal end of regular cone
2-Distal end of long cone	1-
4.6 mGy/s ± 40 %
(60 kV, 3 mA)
9.1 mGy/s ± 40 %
(60 kV, 6 mA)
5.9 mGy/s ± 40 %
(70 kV, 3 mA)
11.8 mGy/s ± 40 %
(70 kV, 6 mA)
2-
2.0 mGy/s ± 40 %
(60 kV, 3 mA)
4.1 mGy/s ± 40 %
(60 kV, 6 mA)
2.6 mGy/s ± 40 %
(70 kV, 3 mA)
5.2 mGy/s ± 40 %
(70 kV, 6 mA)	1-
5.4 mGy/s ± 40 %
(60 kV, 4 mA)
9.4 mGy/s ± 40 %
(60 kV, 7 mA)
7.1 mGy/s ± 40 %
(70 kV, 4 mA)
12.4mGy/s±40%
(70kV, 7 mA)
2-
2.4 mGy/s ± 40 %
(60 kV, 4 mA)
4.2 mGy/s ± 40 %
(60 kV, 7 mA)
3.1 mGy/s ± 40 %
(70 kV, 4 mA)
5.5 mGy/s ± 40 %
(70 kV, 7 mA)	Unknown	1-
8.5 mGy/s ± 40 %
(60 kV, 7 mA)
11 mGy/s ± 40 %
(70 kV, 7 mA)
R. Source to skin distance
1-Regular cone
2-Long cone	1-203 mm
2-305 mm	1-203 mm
2-305 mm	1-200 mm
2-300 mm	1-200 mm
2-300 mm
S. Leaking technique factor	70 kV, 697 mAs	70 kV, 494 mAs	70 kV, 1350 mAs	70 kV, 413 mAs
T. Duty cycle	1 : 30	1 : 50	1 : 15	1 : 60
U. Maximum deviation of tube potential and tube current.	±10 kV, ± 2 mA
(below 0.1sec.
setting)
±5 kV, ±1 mA
(0.1 sec. setting &
up)	±10 kV, ± 2 mA
(below 0.1sec.
setting)
±5 kV, ±1 mA
(0.1 sec. setting &
up)	±5 %
(tube potential)
±1 mA
(tube current)	±5 kV
(tube potential)
±1.4 mA
(tube current)

(7) PERFORMANCE STSTANDARDS APPLIED : AAMI/ANSI ES60601-1, IEC60601-1-2, IEC60601-1-3, IEC60601-1-6, IEC60601-2-65, ISO14971
(Testing for AAMI/ANSI ES60601-1, IEC60601-1-3 and IEC60601-1-6 will be conducted by Intertek, 70 Codman Hill Road, Boxborough, MA 01719 before marketing. Testing for IEC60601-1-2 was conducted by UL Japan Inc. 4383-326 Asama-cho, Ise-shi, Mie-ken 516-0021 JAPAN and confirmed the compliance with the standard. )
(8) CONCLUSION : The PHOT-XIIs Model 505 has the same intended use and technology characteristics as the predicate devices.