(259 days)
K#133544
K#170813, K#073696
No
The summary does not mention AI, ML, deep learning, or any related terms in the device description, intended use, or performance studies. The focus is on standard radiographic imaging techniques and image reconstruction.
No
The device is described as an X-ray unit used for "radiographic examination and diagnosis," indicating its purpose is imaging for diagnostic purposes rather than providing therapy.
Yes
The "Intended Use / Indications for Use" section states that the device is "used for dental and head radiographic examination and diagnosis of teeth, jaw, oral structure, temporomandibular joint, skull including the dento-maxillofacial areas, and hand for maturity assessment". The term "diagnosis" clearly indicates a diagnostic purpose.
No
The device description explicitly lists hardware components such as an x-ray arm, detector, generator, and control assembly, in addition to software.
Based on the provided text, the Veraview X800 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens taken from the human body. The Veraview X800 is an extraoral X-ray unit that directly images the patient's body (teeth, jaw, skull, hand, etc.) using ionizing radiation. It does not analyze biological samples like blood, urine, or tissue.
- The intended use and device description clearly state it's for radiographic examination and diagnosis based on imaging. The device captures images of anatomical structures, which are then viewed and interpreted by a healthcare professional. This is a form of in vivo (within the living body) diagnostic imaging, not in vitro (in glass/outside the body) diagnostics.
Therefore, the Veraview X800 falls under the category of medical imaging devices, not IVD devices.
N/A
Intended Use / Indications for Use
The Veraview X800 is intended to be used for panoramic tomography including linear tomography and scanogram, cephalometric radiography, and cone beam computed tomography.
The Veraview X800 is an extraoral source X-ray unit that is used for dental and head radiographic examination and diagnosis of teeth, jaw, oral structure, temporomandibular the dento-maxillofacial areas, and hand for maturity assessment, by exposing an X-ray image receptor to ionizing radiation.
The device uses a cone shaped X-ray beam projected onto a flat panel detector, and the examined volume image is reconstructed to be viewed in 2D or 3D viewing stations.
The device is to be operated and used by dentists and other legally qualified professionals for pediatric and adult patients.
Product codes (comma separated list FDA assigned to the subject device)
OAS
Device Description
The Veraview X800 consists of the following components: x-ray arm with extraoral x-ray source assembly faced with x-ray detector, cephalometric support, high-voltage generator, control assembly, patient positioning device, and software containing communication and image construction.
The Veraview X800 has three main radiographic modes as follows:
- Panoramic tomography including linear tomography and scanogram -
- Cephalometric radiography -
- -Cone beam computed tomography
Mentions image processing
The device uses a cone shaped X-ray beam projected on to a flat panel detector, and the examined volume image is reconstructed to be viewed in 2D or 3D viewing stations.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
teeth, jaw, oral structure, temporomandibular joint, skull including the dento-maxillofacial areas, and hand
Indicated Patient Age Range
pediatric and adult patients
Intended User / Care Setting
dentists and other legally qualified professionals
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)
Non-clinical testing was conducted on the new device including imaging performance for all three modes of operation (panoramic, cephalometric, and CBCT).
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.
K#133544
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.
K#170813, K#073696
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
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
December 19, 2017
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
J.Morita USA, Inc. % Keith Barritt Attorney Fish & Richardson P.C. 1425 K Street, N.W., Suite 1100 Washington, DC 20005
Re: K171012
Trade/Device Name: Veraview X800 Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-Ray System Regulatory Class: Class II Product Code: OAS Dated: March 30, 2017 Received: April 4, 2017
Dear Keith Barritt:
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 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);
1
Page 2 - Keith Barritt
and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Robert Ochs
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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K#171012
Device Name Veraview X800 X-Ray System
Indications for Use (Describe)
The Veraview X800 is intended to be used for panoramic tomography including linear tomography and scanogram, cephalometric radiography, and cone beam computed tomography.
The Veraview X800 is an extraoral source X-ray unit that is used for dental and head radiographic examination and diagnosis of teeth, jaw, oral structure, temporomandibular the dento-maxillofacial areas, and hand for maturity assessment, by exposing an X-ray image receptor to ionizing radiation.
The device uses a cone shaped X-ray beam projected onto a flat panel detector, and the examined volume image is reconstructed to be viewed in 2D or 3D viewing stations.
The device is to be operated and used by dentists and other legally qualified professionals for pediatric and adult patients.
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 J. Morita USA Inc. Veraview X800 X-ray system for Panoramic, Cephalometric and CBCT imaging
The following information is provided pursuant to 21 CFR 807.92.
807.92(a)(1): Submitter's Name/Address, Contact, and Preparation Date
(i) 510(k) Submitter
Registration No. 2081055 J. Morita USA, Inc. 9 Mason, Irvine, CA 92618, USA Phone: 949-581-9600 Fax: 949-581-9688
(ii) 510(k) Submitter Contact
Keith A. Barritt Fish & Richardson P.C. 901 15th Street, Suite 700 Washington DC 20005, USA Phone: (202) 783-5070 Fax: (202) 783-2331 Email: barritt@fr.com
(iii) Preparation Date
December 14, 2017
807.92(a)(2): Name of Device
| Trade or Proprietary Name: | Veraview X800 |
|---|---|
| Model Name: | X800 |
| Common Name: | Dental Computed Tomography X-ray System imaging |
| Classification Name: | Computed tomography x-ray system |
| Device Classification Panel: | Class II, Radiology |
| Product Code: | OAS |
| Regulation: | 21 CFR 892.1750 |
4
807.92(a)(3): Predicate Device
The Veraview X800 is substantially equivalent for purposes of FDA medical device regulations to the following primary predicate device:
| Trade or Proprietary Name: | OP300 (K#133544) |
|---|---|
| Common Name: | Dental panoramic cephalometric and cone beam computed |
| tomography x-ray device | |
| Classification Name: | Computed tomography x-ray system |
| Device Classification Panel: | Class II, Radiology |
| Product Code: | OAS |
| Regulation: | 21 CFR 892.1750 |
K#170813 is a secondary/reference predicate device:
| Trade or Proprietary Name: | ORTHOPANTOMOGRAPH™ OP 3D (K#170813) |
|---|---|
| Common Name: | X-ray, Tomography, Computed, Dental |
| Classification Name: | Computed tomography x-ray system |
| Device Classification Panel: | Class II, Radiology |
| Product Code: | OAS |
| Regulation: | 21 CFR 892.1750 |
- J. MORITA CORP.'s own X550 (K#073696) is a secondary/reference predicate device:
| Common Name: | Dental Panoramic/Cephalometric X-ray System with CT
Capability | |
|------------------------------|-------------------------------------------------------------------|--|
| Classification Name: | Extra-oral source dental x-ray system | |
| Device Classification Panel: | Class II, Radiology | |
| Product Code: | MUH | |
| Regulation: | 21 CFR 872.1800 | |
807.92(a)(4): Device Description
The Veraview X800 consists of the following components: x-ray arm with extraoral x-ray source assembly faced with x-ray detector, cephalometric support, high-voltage generator, control assembly, patient positioning device, and software containing communication and image construction.
The Veraview X800 has three main radiographic modes as follows:
- Panoramic tomography including linear tomography and scanogram -
- Cephalometric radiography -
- -Cone beam computed tomography
5
807.92(a)(5): Intended Use
The intended use of the X800 is:
- Panoramic tomography including linear tomography and scanogram -
- Cephalometric radiography -
- Cone beam computed tomography -
The intended use of the primary predicate device is:
The OP300 dental panoramic, cephalometric and cone beam computed tomography x-rav device is intended for dental radiographic examination of teeth, jaw and TMJ areas by producing conventional 2D x-ray images as well as x-ray projection images of an examined volume for the reconstruction of a 3D view. The device is operated and used by qualified healthcare professionals.
Indication for Use
Veraview X800 is intended to be used for panoramic tomography including linear tomography and scanogram, cephalometric radiography, and cone beam computed tomography. Veraview X800 is an extraoral source X-ray unit that is used for dental and head radiographic examination and diagnosis of teeth, jaw, oral structure, temporomandibular joint, skull including the dento-maxillofacial areas, and hand for maturity assessment, by exposing an X-ray image receptor to ionizing radiation.
The device uses a cone shaped X-ray beam projected on to a flat panel detector, and the examined volume image is reconstructed to be viewed in 2D or 3D viewing stations.
The device is to be operated and used by dentists and other legally qualified professionals for pediatric and adult patients.
807.92(a)(6): Technological Characteristics
Comparison tables of the Veraview X800 and (1) the primary predicate K#133544 and reference device K#170813 and (2) the reference device K#073696 appear below:
6
| Proposed device | Primary predicate device (ORTHOPANTOMOGRAPH™ OP300, K133544) | Reference predicate device (ORTHOPANTOMOGRAPH™ OP 3D, K170813) | |
|---|---|---|---|
| 1 | |||
| Indications for Use/ | |||
| Intended Use | Veraview X800 is intended to be used for panoramic tomography including linear tomography and scanogram, cephalometric radiography, and cone beam computed tomography. Veraview X800 is an extraoral source X-ray unit that is used for dental and head radiographic examination and diagnosis of teeth, jaw, oral structure, temporomandibular joint, skull including the dento-maxillofacial areas, and hand for maturity assessment, by exposing an X-ray image receptor to ionizing radiation. The device uses a cone shaped X-ray beam projected on to a flat panel detector, and the examined volume image is reconstructed to be viewed in 2D or 3D viewing stations. The device is to be operated and used by dentists and other legally qualified professionals for pediatric and adult patients | The OP300 dental panoramic, cephalometric and cone beam computed tomography x-ray device is intended for dental radiographic examination of teeth, jaw and TMJ areas by producing conventional 2D x-ray images as well as x-ray projection images of an examined volume for the reconstruction of a 3D view. The device is operated and used by qualified healthcare professionals. | ORTHOPANTOMOGRAPH™ OP 3D is an x-ray device to take panoramic and 3D images of the craniomaxillofacial complex for use in diagnostic support. ORTHOPANTOMOGRAPH™ OP 3D must only be used and operated by dentist and other qualified professionals |
Comparison table for the primary predicate K133544 and reference K#170813 devices:
7
| | | Proposed device | Primary predicate
device
(ORTHOPANTOMO
GRAPH™ OP300,
K133544) | Reference predicate device
(ORTHOPANTOMOGRAPH™
OP 3D, K170813) |
|----|------------------------------------------------------|----------------------------------------------------------------|---------------------------------------------------------------------------|-----------------------------------------------------------------------|
| 2 | Imaging
modes | Panoramic
CBCT
Cephalometric | Panoramic
CBCT
Cephalometric | Panoramic
CBCT |
| 3 | Focal spot | 0.5 | 0.5 | 0.5 |
| 4 | Image
detector | CMOS Flat Panel +CCD
detector
(ceph) | CMOS Flat Panel
+CMOS detector
(Pan/ceph) | CMOS Flat Panel |
| 5 | CBCT
imaging
technique | Reconstruction from 2D
images | Reconstruction from
2D images | Reconstruction from 2D images |
| 6 | CBCT's
Field Of
View
(cm) | 4 x 4
8 x 4, 5, 8
10 x 4, 5, 8
15 x 5, 7.5, 14 | 5x5
6x8
8x8
8x15
13x15 | 5 x 5
6 x 9
9 x 11
9 x 14 |
| 7 | CBCT's
total
viewing
angle | 180, 360 degree | 360 degree | 360 degree |
| 8 | CBCT's
effective
exposure
time (s) | Scout: 0.5, 1.0
CBCT: 9.4, 17.9
17.9 x 2 for FOV 15 x 14 | 1.2 - 12.5 | 1.7 - 20 |
| 9 | CBCT
Reconstru
ction
Time | 1-6 min. (depending on
the computer
specification) | 1-3 min. | 1-3 min. |
| 10 | Patient's
Position | Standing and wheelchair | Standing and
wheelchair | Standing and wheelchair |
| 11 | System
footprint
(includes
the
operator) | H218.5-232.5cm D120cm
W140-200 cm | H161-241cm
D139cm
W97-193 cm | H167-247cm
D77-100cm
130 cm |
| 12 | Weight | Pan/CBCT 185-190 kg
Ceph 220-225 kg | Pan/CBCT 205 kg
Ceph 240 kg | 100 kg |
| 13 | Classificat
ion | OAS | OAS | OAS |
| 14 | CBCT
resolution | Standard, high resolution | Low , standard, high,
endo | Low , standard, high, endo |
| | | Proposed device | Primary predicate device
(ORTHOPANTOMO
GRAPHTM OP300,
K133544) | Reference predicate device
(ORTHOPANTOMOGRAPHTM
OP 3D, K170813) |
| | | | | |
| 15 | 2D
imaging
programs | Adult Pan, Child Pan,
TMJ, BW, Partial Pan | Adult Pan, Child Pan,
TMJ, BW,
Partial Pan | Adult Pan, Child Pan, TMJ, BW,
Partial Pan |
| 16 | - | - | - | - |
| 17 | CMOS flat
panel pixel
size | 0.1 mm x 0.1 mm | 100 μm x 100 μm | 99 μm x 99 μm |
| 18 | System
MTF | 2.5 lp/mm @10%
FOV 4x4
High Resolution | 2.25 lp/mm @10%
FOV 5x5
High Resolution | 2.2 lp/mm@10%
FOV 5x5
High Resolution |
8
9
Comparison table for the reference predicate K#073696 is as follows:
| Item | Device submitted in this 510(k) | Reference device | | Loading factors | Tube Potential: 60-100kV
Tube Current: 2-10mA
Loading time: max. 18.5s | Tube Potential: 60-90kV
Tube Current: 1-10mA
Loading time: max. 20.3s |
|---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product name | Veraview X800 | Veraviewepocs | Design | X-ray tube
assembly | Nominal focal spot: 0.5 at target
angle
Inherent filtration min. 2.5mmAL | Nominal focal spot: 0.5 at target
angle
Inherent filtration min.
2.5mmAL |
| Model | X800 | X550 | | X-ray detector 1 | Internal parts code: D001-15038-
50*
See column in predicate device. | Internal parts code: D001-
15038-50*
CMOS flat panel
Scintillator: CsI
Pixel size for Pan: 0.1 mm
Pixel size for CBCT: 0.1 mm,
0.2 mm |
| Manufacturer | J. MORITA MFG. CORP. | J. MORITA MFG. CORP. | | X-ray detector 2 | Internal parts code: D001-16044-
50*
CMOS flat panel
Scintillator: CsI
Pixel size for Pan: 0.1 mm
Pixel size for CBCT: 0.1 mm,
0.2 mm | Internal parts code: D00-
113030-50*
CMOS flat panel
Scintillator: CsI
Pixel size for Pan and CBCT:
0.2 mm |
| Indications for use | Veraview X800 is intended to be
used for panoramic tomography
including linear tomography and
scanogram, cephalometric
radiography, and cone beam
computed tomography.
Veraview X800 is an extraoral
source X-ray unit that is used for
dental and head radiographic
examination and diagnosis of
teeth, jaw, oral structure,
temporomandibular joint, skull
including the dento-maxillofacial
areas, and hand for maturity
assessment, by exposing an X-ray
image receptor to ionizing
radiation.
The device uses a cone shaped X-
ray beam projected on to a flat
panel detector, and the examined
volume image is reconstructed to
be viewed in 2D or 3D viewing
stations.
The device is to be operated and
used by dentists and other legally
qualified professionals for
pediatric and adult patients. | The Veraviewepocs is an
extraoral source X-ray unit that
is used for dental radiographic
examination and diagnosis of
teeth, jaw, oral structure, TM-
joints and skull including the
ENT and dento-maxillofacial
areas, by exposing an X-ray
image receptor to ionizing
radiation.
The device uses cone shaped X-
ray beam projected on to a flat
panel detector, and the examined
volume image is reconstructed to
be viewed in 2D or 3D viewing
stations.
The device is to be operated and
used by dentists and other
legally qualified professionals. | | X-ray detector 3 | Internal parts code: D001-04188-
50*
See column in predicate device. | Internal parts code: D001-
04188-50*
CCD line sensor
Scintillator: CsI
Pixel size for Ceph: 0.1 mm |
| Energy used and/or
delivered | AC 120 V, 60 Hz | AC 120 V, 60 Hz | | Soft-
ware | Viewer
(general purpose
viewer: not
included in this
submission of
the device) | Viewer software:
510K number: K073704
Device name: i-Dixel |
10
11
| | Panoramic
- spatial
resolution | Line pair resolution on IEC
61223-3-4: min. 2.5 LP/mm | Line pair resolution: min. 2.5
LP/mm |
|--------------------------|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| Perfor | Panoramic - noise | Low contrast resolution on IEC
61223-3-4: min. diameter 2.0 mm
at High speed mode, min.
diameter 1.0 mm at High
resolution mode | Low contrast resolution on IEC
61223-3-4: min. diameter 2.0
mm |
| | mance | Cephalometric - spatial
resolution | Line pair resolution on IEC
61223-3-4: min. 2.5 LP/mm |
| Cephalometric - noise | | Low contrast resolution on IEC
61223-3-4: min. diameter 2.5 mm | Low contrast resolution on IEC
61223-3-4: min. diameter 2.5
mm |
| | CBCT - spatial
resolution | min. 10% MTF at 2.0 LP/mm at
standard mode
min. 10% MTF at 2.5 LP/mm at
high resolution mode | min. 10% MTF at 2.0 LP/mm |
| | CBCT - noise | The standard deviation of the gray
scale of the center region of the
Contrast phantom shall be less
than 12.5 (10% of the full scale). | The standard deviation of the gray
scale of the center region of the
Contrast phantom shall be
less than 12.5 (10% of the full
scale). |
807.92(b)(l): Non-clinical Testing
The Veraview X800 has been tested for compliance and developed in accordance with the following international standards:
| IEC/ISO Standard | FDA Recognition number |
|---|---|
| IEC 60601-1:2005+A.MD1:2012 | 19-4 |
| IEC 60601-1-2:2007 | 19-1 |
| IEC 60601-1-3:2008+AMD1: 2013 | 12-269 |
| IEC 60601-1-6:2010+AMD1:2013 | 5-89 |
| IEC 60601-2-54:2009+AMD1:2015 | 12-296 |
| IEC 60601-2-63:2012 | 12-251 |
| IEC 61223-3-4:2000 | 12-224 |
| IEC 62304:2006+AMD1:2015 | 13-79 |
| IEC 62366:2007+AMD1:2014 | 5-87 |
| ISO 10993-1:2009/Cor1:2010 | 2-220 |
| ISO 14971:2007 | 5-40 |
12
In addition to conformance with the above standards, non-clinical testing was conducted on the new device including imaging performance for all three modes of operation (panoramic, cephalometric, and CBCT).
807.92(b)(2): Clinical Testing
There were no clinical tests performed for Veraview X800.
807.92(b)(3): Conclusions from Testing
Based on the comparison of the Veraview X800 to the primary and reference predicates identified above and based on the non-clinical testing described above, it is concluded that the Veraview X800 is substantially equivalent to the primary predicate device.
The Veraview X800 device has the same intended use as the predicate device, and also offers the same imaging modalities as the predicate device (panoramic, cephalometric, and CBCT). Non-clinical testing demonstrates that the device performs in a substantially equivalent manner to the predicate device with regard to imaging and dose performance. Finally, the safety and overall performance of the device are demonstrated via conformance to the above stated applicable standards.