(126 days)
Not Found
No
The summary mentions "Digital processing" but does not mention AI, ML, or any related terms, nor does it describe any features or performance metrics typically associated with AI/ML algorithms.
No
The device is used for generating radiographic images for dental examination and diagnosis, not for treating diseases or conditions.
Yes
The device is indicated for "diagnosis of diseases of the tooth, jaw, and oral structures" and has "diagnostic panoramic and TMJ imaging capabilities," directly linking its use to diagnosis.
No
The device description explicitly states it is a "digital panoramic X-ray system" and mentions hardware components like a "high frequency inverter" and "X-Ray tube housing," indicating it is a hardware device with integrated software, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to generate radiographic images of the dento-maxilofacial region for dental examination and diagnosis of diseases of the tooth, jaw, and oral structures. This involves imaging the physical structure of the body, not analyzing biological samples (like blood, urine, or tissue) outside of the body.
- Device Description: The description focuses on the hardware and imaging capabilities of an X-ray system.
- Input Imaging Modality: The input is X-ray, which is an imaging modality used to visualize internal structures, not to analyze biological samples.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device is an imaging system used to create visual representations of anatomical structures.
N/A
Intended Use / Indications 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.
Product codes (comma separated list FDA assigned to the subject device)
MUH
Device Description
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.
Mentions image processing
Digital processing
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
dentomaxilofacial region, tooth, jaw, oral structures
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)
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 the predicate device.
X-Ray tube housing was tested and confirmed that new X-Ray housing conforms to IEC60601-1-3 and 21CFR 1020.30(k).
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.
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
§ 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.
0
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 stylized caduceus symbol, which features three human profiles facing right, connected by a flowing ribbon-like form. The symbol is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
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.
1
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/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 (800) 638-2041 or (301) 796-7100 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
2
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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary (as required by 807.92)
(1) SUBMITTER: Takara Belmont Corporation, LTD. Address: 1-1-2 Chome, Higashi-Shinsaibashi, Chuo-ku Telephone: 81-6-6213-5945 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 | |
| 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. | IFU Statement: The Bel-Cypher N 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. |
4
510(k) Premarket Notification for Bel-Cypher Pro Takara Belmont Corporation, Ltd.
| 1.
COMPARISON
TABLE
OF
SPECIFICATIONS
Specifications | Takara Belmont
Bel-Cypher N | Takara Belmont
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
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
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
2.5sec(×4) at TMJ mode | 10 sec at Panoramic mode
10 sec at TMJ (LA) mode
2.5sec(×4) at TMJ mode |
| Dimension | W:920mm×D:1100mm
xH:2200mm | W:850mm×D:1135mm
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
permanently in useful
beam | 2.8mmAl (80kV) | 2.5mmAl (80 kV) |
| Nominal roentgen output:
panoramic mode | 9.34 mGy / 10 sec ±50%
(80kv,80mA) | 9.34 mGy / 10 sec ±50%
(80kv,80mA) |
| Nominal roentgen output:
TMJ mode | 9.34 mGy / 10 sec ±50%
(80kv,80mA) | 9.34 mGy / 10 sec ±50%
(80kv,80mA) |
| Nominal roentgen output:
MS mode | N/A | N/A |
| Nominal roentgen output:
Cephalo mode | N/A | N/A |
| Source to image distance | 500 mm | 500 mm |
5
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 | |
| interval | 10 sec exposure with 8 min | |
| interval | ||
| Bitewing | 4.6 sec exposure with 4.5 min | |
| interval | ||
| TMJ: | 2.5sec(x4) exposure with 3 | |
| min off interval | 2.5sec(x4) exposure with 2.5 | |
| min off interval | ||
| Maximum deviation of tube potential | The selected kV ± 10 % | The selected kV ± 10 % |
| Maximum deviation of tube current | The selected mA | |
| ± 20 % | The selected mA | |
| ± 20 % | ||
| Equipment type | Type B equipment | Type B equipment |
6
| Specifications | Takara Belmont
Bel-Cypher N | Takara Belmont
Bel-Cypher Pro |
|----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| Mechanical | | |
| Cassette type sensor
package: Size | (W) 90mmx (D) 51.2 mmx
(H) 174mm | (W) 90mm x (D) 23.7mm
x (H)165mm |
| Cassette type sensor
package: Weight | 0.5 kg | 0.5 kg |
| Electrical | | |
| Safety and EMC
standards Compliance | Safety:IEC60601-1
EMC:CISPR11 Class A | Safety:IEC60601-1
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
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
current protection function and
the over voltage protection
function | The power supply has the over
current protection function and
the over voltage protection
function |
| Restricted
service
statement | Unless otherwise specified,
this unit should be serviced
only by the manufacturer. It
contains no user-serviceable
parts. | Unless otherwise specified,
this unit should be serviced
only by the manufacturer. It
contains no user-serviceable
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
(Sensor specifications) | 4.5 line pairs per millimeter | 4.2 line pairs per millimeter |
| Noise (rms) | 800 electrons | 640 electrons |
| Timing Characteristics | | |
| Timeout after
loss of
synchronization | N/A | N/A |
| Timeout when
starting
acquisition | N/A | N/A |
7
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:
-
More sensitive CMOS sensor.
-
Up/Down movement of the unit is motorized for easy operation.
Up/Down movement of Bel-Cypher N was manual.
- 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.
- 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).
8
(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.