Bel-Cypher Pro

K163175 · Takara Belmont Corporation · MUH · Mar 20, 2017 · Dental

Device Facts

• Record ID: K163175
• Device Name: Bel-Cypher Pro
• Applicant: Takara Belmont Corporation
• Product Code: MUH · Dental
• Decision Date: Mar 20, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.1800
• Device Class: Class 2

Intended Use

The Bel-Cypher Pro dental panoramic X-ray system is indicated for use as generator of radiographic images of the dentomaxilofacial region and is intended for dental examination and diagnosis of the tooth, jaw, and oral structures.

Device Story

Bel-Cypher Pro is a digital panoramic X-ray system for dental imaging. It utilizes a high-frequency inverter and small focal spot to generate radiographic images of the dentomaxilofacial region. The system supports panoramic, bitewing, and TMJ imaging modes. It features a motorized up/down movement for patient positioning. The device is operated by dental professionals in a clinical setting. It captures X-ray signals via a CMOS sensor, which are then processed digitally. The system connects to external computer hardware via Giga Ethernet for image acquisition, reconstruction, and storage. The output consists of digital dental images used by clinicians for diagnostic purposes, aiding in the assessment of oral health and disease. The device benefits patients by providing clear diagnostic images for treatment planning.

Clinical Evidence

Bench testing only. Performance was verified through comparative testing of all radiographic modes against the predicate device, confirming equivalent image quality. The X-ray tube housing was tested for compliance with IEC 60601-1-3 and 21 CFR 1020.30(k). Software modifications were validated for compatibility with Windows 7, 8, and 10 environments.

Technological Characteristics

Extraoral X-ray system; high-frequency inverter; CMOS sensor (149.8mm x 6mm active area); 0.5mm x 0.5mm focal spot; 60-80 kV tube potential; 2-8 mA tube current; stainless steel/aluminum tube housing; Giga Ethernet connectivity; motorized positioning; Type B equipment; IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-63 compliance.

Indications for Use

Indicated for dental examination and diagnosis of tooth, jaw, and oral structures in the dentomaxilofacial region.

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

• Bel-Cypher N (K110160)

Submission Summary (Full Text)

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

March 20, 2017

Takara Belmont Corporation, Ltd. % Dr. Robert Schiff President Schiff & Company, Inc. 1120 Bloomfield Avenue, Suite 103 WEST CALDWELL NJ 07006

Re: K163175

Trade/Device Name: Bel-Cypher Pro Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH Dated: February 24, 2017 Received: February 24, 2017

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.

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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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael D'Hara

For

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K163175

Device Name

Bel-Cypher Pro

Indications for Use (Describe)

The Bel-Cypher Pro dental panoramic X-ray system is indicated for use as generator of radiographic images of the dentomaxilofacial region and is intended for dental examination and diagnosis of the tooth, jaw, and oral structures.

| Type of Use (Select one or both, as applicable) | |
|---------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|
| <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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### 510(k) Summary (as required by 807.92)

(1) SUBMITTER: Takara Belmont Corporation, LTD. Address: 1-1-2 Chome, Higashi-Shinsaibashi, Chuo-ku Telephone: [phone] Contact person: Toshinori Kiyomatsu Date prepared: October 2016

#### (2) DEVICE NAME:

Trade Name: Bel-Cypher Pro Classification Name: Extraoral Source x-ray system Requlation Number: 872.1800 Product Code: MUH

(3) PREDICATE DEVICE: Substantial equivalence is based on following legally marketed

K110160 Bel-Cypher N (Cleared 02/17/2011) Trade Name: Bel-Cypher N Common Name: System, X-Ray, Extraoral Source, Digital Classification Name: Extraoral Source x-ray system Regulation Number: 872.1800 Product Code: MUH

#### (4) DESCRIPTION OF THE DEVICE:

The Bel-Cypher Pro is a user-friendly, digital panoramic X-ray system that features bitewing imaging capability, as well as diagnostic panoramic and TMJ imaging capabilities. The Bel-Cypher Pro utilizes a high frequency inverter and has a small focal spot to produce crisp, clear images.

- (5) INDICATION FOR USE: The Bel-Cypher Pro dental panoramic X-ray system is indicated for use as generator of radiographic images of the dento-maxilofacial region and is intended for dental examination and diagnosis of diseases of the tooth, jaw, and oral structures.
- (6) COMPARISON WITH PREDICATE DEVICES: Following table is a comparison of our new Bel-Cypher Pro and predicate device Bel-Cypher N.

| Bel-Cypher Pro (New model) | Bel-Cypher N (K110160) |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| IFU Statement: The Bel-Cypher Pro dental<br>panoramic X-ray system is indicated for use as<br>generator of radiographic images of the<br>dento-maxilofacial region and is intended for<br>dental examination and diagnosis of diseases of<br>the tooth, jaw, and oral structures. | IFU Statement: The Bel-Cypher N dental<br>panoramic X-ray system is indicated for use as<br>generator of radiographic images of the<br>dento-maxilofacial region and is intended for<br>dental examination and diagnosis of diseases of<br>the tooth, jaw, and oral structures. |

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### 510(k) Premarket Notification for Bel-Cypher Pro Takara Belmont Corporation, Ltd.

| 1.<br>COMPARISON<br>TABLE<br>OF<br>SPECIFICATIONS<br>Specifications | Takara Belmont<br>Bel-Cypher N | Takara Belmont<br>Bel-Cypher Pro |
|---------------------------------------------------------------------|----------------------------------------------------|-------------------------------------------------------------------------------|
| Focal point measurement | 0.5mm x 0.5mm | 0.5mm x 0.5mm |
| Rated peak tube potential | 60 kV – 80 kV | 60 kV – 80 kV |
| Rated tube current | 2 mA – 8 mA | 2 mA – 8 mA |
| Maximum rated peak<br>tube potential | 80 kV | 80 kV |
| Rated line voltage | 120 Vac | 120 Vac |
| Line voltage range | 110 Vac – 130 Vac | 110 Vac – 130 Vac |
| Range of line voltage<br>regulation | 1 – 3 % | 1 – 3 % |
| Rated line current | 11 A at 80 kV – 8 mA | 11 A at 80 kV – 8 mA |
| Maximum line current | 11 A at 80 kV – 8 mA | 11 A at 80 kV – 8 mA |
| Exposure time | 10 sec at Panoramic mode<br>2.5sec(×4) at TMJ mode | 10 sec at Panoramic mode<br>10 sec at TMJ (LA) mode<br>2.5sec(×4) at TMJ mode |
| Dimension | W:920mm×D:1100mm<br>xH:2200mm | W:850mm×D:1135mm<br>xH:2275mm |
| Weight | 130kg | 105kg |
| Timer accuracy | ± 5 % + 50msec | ± 5 % + 50msec |
| Inherent filtration | 2.05 mm Al equivalent | 3.4 mm Al equivalent |
| Added filtration | 1.5 mmAl | 1.5 mmAl |
| Minimum filtration<br>permanently in useful<br>beam | 2.8mmAl (80kV) | 2.5mmAl (80 kV) |
| Nominal roentgen output:<br>panoramic mode | 9.34 mGy / 10 sec ±50%<br>(80kv,80mA) | 9.34 mGy / 10 sec ±50%<br>(80kv,80mA) |
| Nominal roentgen output:<br>TMJ mode | 9.34 mGy / 10 sec ±50%<br>(80kv,80mA) | 9.34 mGy / 10 sec ±50%<br>(80kv,80mA) |
| Nominal roentgen output:<br>MS mode | N/A | N/A |
| Nominal roentgen output:<br>Cephalo mode | N/A | N/A |
| Source to image distance | 500 mm | 500 mm |

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# 510(K) PREMARKET NOTIFICATION FOR BEL-CYPHER PRO

| Leakage technique factor | 0.0014mR/80kV,8mA | 0.077mR/80kV,8mA |
|-------------------------------------|------------------------------------------------|--------------------------------------------------|
| Duty cycle | 1:60 | 1:60 |
| Panoramic: | 10 sec exposure with 8 min<br>interval | 10 sec exposure with 8 min<br>interval |
| Bitewing | | 4.6 sec exposure with 4.5 min<br>interval |
| TMJ: | 2.5sec(x4) exposure with 3<br>min off interval | 2.5sec(x4) exposure with 2.5<br>min off interval |
| Maximum deviation of tube potential | The selected kV ± 10 % | The selected kV ± 10 % |
| Maximum deviation of tube current | The selected mA<br>± 20 % | The selected mA<br>± 20 % |
| Equipment type | Type B equipment | Type B equipment |

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| Specifications | Takara Belmont<br>Bel-Cypher N | Takara Belmont<br>Bel-Cypher Pro |
|----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| Mechanical | | |
| Cassette type sensor<br>package: Size | (W) 90mmx (D) 51.2 mmx<br>(H) 174mm | (W) 90mm x (D) 23.7mm<br>x (H)165mm |
| Cassette type sensor<br>package: Weight | 0.5 kg | 0.5 kg |
| Electrical | | |
| Safety and EMC<br>standards Compliance | Safety:IEC60601-1<br>EMC:CISPR11 Class A | Safety:IEC60601-1<br>EMC:CISPR11 Class B |
| Maximum line voltage | DC 5 V | DC 9 V |
| Environmental | | |
| Operating temperature | 0 to 40°C | 0 to 40°C |
| Storage temperature | -10 to 60°C | -10 to 60°C |
| Humidity | under 93%±3% RH | under 93%±3% RH |
| Highest permissible<br>temperature limit | 60°C | 60°C |
| General | | |
| Acquisition sensor | CMOS sensor | CMOS sensor |
| Digital processing | Digital | Digital |
| Computer interface board | Not included with the device | Not included with the device |
| External connectivity | Giga Ethernet | Giga Ethernet |
| Acquisition software | Not included with the device | Not included with the device |
| Enhancement functions | Not included with the device | Not included with the device |
| Digital storage | Not included with the device | Not included with the device |
| Hard copy | Not included with the device | Not included with the device |
| Image sensor active area | 148 mmx 6 mm | 149.8mm x 6mm |
| Maximum Flame rate | 300f/s | 400f/s |
| Calibration | Automatic | Automatic |
| System and Component information | | |
| Input electrical ratings | DC 5 V | DC 24 V |
| Equipment type | Type B equipment | Type B equipment |
| Fuses | The power supply has the over<br>current protection function and<br>the over voltage protection<br>function | The power supply has the over<br>current protection function and<br>the over voltage protection<br>function |
| Restricted<br>service<br>statement | Unless otherwise specified,<br>this unit should be serviced<br>only by the manufacturer. It<br>contains no user-serviceable<br>parts. | Unless otherwise specified,<br>this unit should be serviced<br>only by the manufacturer. It<br>contains no user-serviceable<br>parts. |
| Image characteristics | | |
| Effective pixel size | 100μm x 100μm | 120μm x 120μm |
| MTF | 49%(@1LP/mm) | 52%(@1LP/mm) |
| DQE | 45%(@1LP/mm) | 44%(@1LP/mm) |
| Static resolution<br>(Sensor specifications) | 4.5 line pairs per millimeter | 4.2 line pairs per millimeter |
| Noise (rms) | 800 electrons | 640 electrons |
| Timing Characteristics | | |
| Timeout after<br>loss of<br>synchronization | N/A | N/A |
| Timeout when<br>starting<br>acquisition | N/A | N/A |

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#### 510(K) Premarket Notification for Bel-Cypher Pro Takara Belmont Corporation, Ltd.

## Differences:

There are four minor differences between the Bel-Cypher Pro and the predicate device which is as follows:

1. More sensitive CMOS sensor.

2. Up/Down movement of the unit is motorized for easy operation.

Up/Down movement of Bel-Cypher N was manual.

3. TWAIN software for Bel-Cypher Pro was developed to work with newer operating system (Windows 7. 8 & 10).

We made the sensor driver compatible with windows 10.

Exe files and DLLs of Radiograph software and image reconstruction software were developed under Windows 10 environment.

4. The hosing structure of X-Ray tube was changed to reduce usage of lead.

The housing of predicate device was constructed by soldering brass plates.

The housing of Bel-Cypher Pro uses 6mm stainless steel plates and aluminum plates to make hermetic sealed housing.

We tested and confirmed that new X-Ray housing conforms to IEC60601-1-3 and 21CFR 1020.30(k).

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#### (7) PERFORMANCE STANDARDS APPLIED:

- AAMI / ANSI ES60601-1:2005((R)2012 And A1:2012,, C1:2009(R)2012 And A2:2010/(R)2012 (Consolidated Text) Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance
- IEC 60601-1-2:2007/(R)2012, Medical Electrical Equipment Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements And Tests.
- IEC 60601-1-3 Edition 2.1 2013-04, Medical Electrical Equipment Part 1-3: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Radiation Protection In Diagnostic X-Ray Equipment.
- IEC 60601-2-28 Edition 2.0 2010-03, Medical Electrical Equipment Part 2-28: Particular Requirements For The Basic Safety And Essential Performance Of X-Ray Tube Assemblies For Medical Diagnosis.
- IEC 60601-2-63 Edition 1.0 2012-09, Medical Electrical Equipment Part 2-63: Particular Requirements For The Basic Safety And Essential Performance Of Dental Extra-Oral X-Ray Equipment.
- IEC 60601-2-65 Edition 1.0 2012-09, Medical Electrical Equipment Part 2-65: Particular Requirements For The Basic Safety And Essential Performance Of Dental Intra-Oral-X-Ray Equipment.
- IEC 61223-3-4 First Edition 2000-03, Evaluation And Routine Testing In Medical Imaging Departments - Part 3-4: Acceptance Tests - Imaging Performance Of Dental X-Ray.
- ISO 14971 Second Edition 2007-03-01, Medical Devices Application Of Risk Management To Medical Devices.
- (8) CONCLUSION: The Bel-Cypher Pro has the same intended use and technology characteristics as the predicate device Bel-Cypher N.

Modifications of software were tested and confirmed based on applicable standards. We also tested all of the radiograph modes and conmfirmed images are equvalent to the ones taken by thpredicate device.

X-Ray tube housing was tested and confirmed that new X-Ray housing conforms to IEC60601-1-3 and 21CFR 1020.30(k).

The proposed device is substantially equivalent to the noted predicate and is safe and effective for its intended use.