(217 days)
No
The document describes a standard CT system and explicitly states that the proposed device is identical to the predicate device (K180015) in terms of design and fundamental scientific technology, with the only difference being the trailer kit for transportation. There is no mention of AI or ML in the description of the device's functionality or components.
No
The device is described as a diagnostic imaging system, used for producing images for diagnosis and screening, not for treating conditions.
Yes
The "Intended Use / Indications for Use" section explicitly states, "These scanners are intended to be used for diagnostic imaging".
No
The device is a Computed Tomography X-Ray System, which is a hardware-based imaging modality. The description explicitly lists hardware components like the gantry, X-ray tube, detectors, and patient support. While it includes software for operation and data processing, it is not a software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "Computed Tomography X-Ray System intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes." It is used for "diagnostic imaging" and "low dose CT lung cancer screening." These are all imaging procedures performed on the patient's body.
- Device Description: The description details the components of a CT scanner, including the gantry, patient support, console, and the X-ray system. These are all components involved in acquiring images from within the patient's body using X-rays.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnostic purposes. The provided text does not mention the analysis of any such specimens.
The device is a medical imaging device that uses X-rays to create images of the internal structures of the body. This is distinct from an IVD device.
N/A
Intended Use / Indications for Use
The Incisive CT is a Computed Tomography X-Ray System intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient and equipments and accessories. The Incisive CT is indicated for head, whole body, cardiac and vascular X-ray Computed Tomography applications in patients of all ages.
These scanners are intended to be used for diagnostic imaging and for low dose CT lung cancer screening for the early detection of lung nodules that may represent cancer*. The screening must be performed within the established inclusion criteria of programs / protocols that have been approved and published by either a governmental body or professional medical society.
Besides installed in hospital, the proposed Philips Incisive CT may also be installed on trailer and be transported to designated locations for use. And Incisive CT installed on trailer has the same intended use as installed in hospital.
*Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.
Product codes
JAK
Device Description
The proposed Philips Incisive CT on Trailer is a whole-body computed tomography (CT) X-Ray System featuring a continuously rotating x-ray tube, detectors, and gantry with multi-slice capability. The acquired x-ray transmission data is reconstructed by computer into cross-sectional images of the body taken at different angles and planes. This system also includes signal analysis and display equipment, patient and equipment support, components, and accessories.
The Philips Incisive CT has a 72cm bore and includes a detector array that provides 50cm scan field of view (FOV).
Besides installed in hospital, Philips Incisive CT can also be installed on trailer and be transported to designated locations.
The main components (detection system, the reconstruction algorithm, and the x-ray system) that are used in the proposed Philips Incisive CT on trailer are identical to the currently marketed and predicate Philips Incisive CT (K180015, 20/March/2018).
The components of the proposed Philips Incisive CT on trailer include the following:
- Gantry. The Gantry consists of 4 main internal units:
a. Stator – a fixed mechanical frame that carries HW and SW
b. Rotor – A rotating circular stiff frame that is mounted in and supported by the stator
c. X-Ray Tube (XRT) and Generator, - fixed to the Rotor frame
d. Data Measurement System (DMS) - a detectors array, fixed to the Rotor frame - Patient Support (Couch) - carries the patient in and out through the Gantry bore synchronized with the scan.
- Console - Containing a Host computer and display that is the primary user interface.
- CT on Trailer Kit - Modified Incisive CT installed and secured on trailer requires locking motion parts during trailer transportation and unlocking motion parts before CT operations.
In addition to the above components and the software operating them, each system includes hardware and software for data acquisition, display, manipulation, storage and filming as well as post-processing into views other than the original axial images. Patient supports (positioning aids) are used to position the patient.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Computed Tomography (CT) X-Ray
Anatomical Site
head, whole body, cardiac and vascular
Indicated Patient Age Range
all ages
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
Non-Clinical Performance data: The device complies with 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 60601-1:2005, MOD); IEC 60601-1-2:2014, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests; IEC 60601-1-3:2013 Medical electrical equipment -- Part 1-3: General requirements for basic safety - Collateral standard: Radiation protection in diagnostic X-ray equipment; IEC 60601-1-6:2013 Medical electrical equipment -- Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability; IEC 60601-2-44:2012 Medical electrical equipment - Part 2-44: Particular requirements for the safety of X-ray equipment; IEC 62304:2015 Medical device software -- Software life cycle processes; IEC 62366:2014 Medical Device-Application of Usability Engineering of Medical Devices; ISO14971 Medical devices – Application of risk management to medical devices (Ed. 2.0, 2007); NEMA XR 25-2010 Computed Tomography Dose Check; NEMA XR 28-2013 Supplemental Requirements for User Information and System Function Related to Dose in CT; NEMA XR 29-2013 Standard Attributes on CT Equipment Related to Dose Optimization and Management; Guidance for Industry and FDA Staff – Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (issued May 11, 2005, document number 337); Guidance for Industry and FDA Staff – Content of Premarket Submissions for Management of Cybersecurity in Medical Devices (issued October 2, 2014); Guidance for Industry and FDA Staff – Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process" (issued June 16, 2016); Guidance for Industry and FDA Staff – Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices (issued July 11, 2016).
Additionally, the Philips Incisive CT complies with performance standards for Computed Tomography (CT) Equipment and Laser products (21 CFR 1020.33 and 21 CFR 1040.10, respectively).
The proposed Philips Incisive CT on Trailer is identical to the currently marketed and predicate Philips Incisive CT (K180015) with regards to intended use, design and fundamental scientific technology except for trailer kit that is utilized to securely mount the CT system on the trailer. The trailer kit consists of locking mechanism that lock the gantry and couch parts of the CT System to the trailer.
With regards to transportation testing the proposed Philips Incisive CT on Trailer complies with Department of Defense Test Method Standard for Environmental Engineering Considerations and Laboratory Tests (MIL- STD-810F). Method 514.5: Composite wheeled vehicle vibration exposures, as described in the main body, Annex A, Annex B and Annex C of this method.
Philips Incisive CT on Trailer has passed the vibration test of 300 hours to simulate a 10 years or 120,690 kM lifetime with QA test including MeanCT, Uniformity, Noise, Spatial Resolution, Slice Thickness, Linearity and Low Contrast Resolution.
The QA test process and acceptance criteria are same as the predicate device, this can demonstrate the Philips Incisive CT on Trailer performs as well as the predicate device.
Clinical Data: Clinical data is not warranted to demonstrate safety and effectiveness of the proposed Philips Incisive CT on Trailer since its design, intended use and fundamental scientific technology is identical to the currently marketed and predicate Philips Incisive CT (K180015, 20/March/2018).
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym and full name on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name, "U.S. Food & Drug Administration," written out next to it.
November 22, 2021
Philips Healthcare (Suzhou) Co., Ltd. % Shiguang An Regulatory Affairs Engineer No. 258, ZhongYuan Road, Suzhou Industrial Park Suzhou. Jiangsu 215024 CHINA
Re: K211168
Trade/Device Name: Philips Incisive CT on Trailer Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: JAK Dated: October 19, 2021 Received: October 19, 2021
Dear Shiguang An:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
, for
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K21168
Device Name Philips Incisive CT on Trailer
Indications for Use (Describe)
The Incisive CT is a Computed Tomography X-Ray System intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient and equipments and accessories. The Incisive CT is indicated for head, whole body, cardiac and vascular X-ray Computed Tomography applications in patients of all ages.
These scanners are intended to be used for diagnostic imaging and for low dose CT lung cancer screening for the early detection of lung nodules that may represent cancer*. The screening must be performed within the established inclusion criteria of programs / protocols that have been approved and published by either a governmental body or professional medical society.
Besides installed in hospital, the proposed Philips Incisive CT may also be installed on trailer and be transported to designated locations for use. And Incisive CT installed on trailer has the same intended use as installed in hospital.
*Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.
| 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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510(k) Summary or Statement
This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR §807.92.
| Date Prepared: | March 30, 2021 |
|---|---|
| Manufacturer: | Philips Healthcare (Suzhou) Co., Ltd. |
| No. 258, ZhongYuan Road, Suzhou Industrial Park, 215024 | |
| Suzhou, Jiangsu Province, PEOPLE'S REPUBLIC OF CHINA | |
| Establishment Registration Number: 3009529630 | |
| Contact Person: | Shiguang An |
| Advanced Regulatory Engineer | |
| Phone cell: +86-139-40106467 | |
| Fax: +86-512-68018677 | |
| E-mail: shiguang.an@philips.com | |
| Device Name: | Philips Incisive CT on Trailer |
| Classification: | Classification Name: Computed tomography x-ray system |
| Classification Regulation: 21CFR §892.1750 | |
| Classification Panel: Radiology | |
| Device Class: Class II | |
| Primary product code: JAK | |
| Predicate Device: | Trade Name: Philips Incisive CT |
| Manufacturer: Philips Healthcare (Suzhou) Co., Ltd. | |
| 510(k) Clearance: K180015-March 20, 2018 | |
| Classification Regulation: 21 CFR, Part 892.1750 | |
| Classification Name: Computed tomography x-ray system | |
| Classification Panel: Radiology | |
| Device Class: Class II | |
| Product Code: JAK |
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| Device description: | The proposed Philips Incisive CT on Trailer is a whole-
body computed tomography (CT) X-Ray System featuring a
continuously rotating x-ray tube, detectors, and gantry with
multi-slice capability. The acquired x-ray transmission data
is reconstructed by computer into cross-sectional images of
the body taken at different angles and planes. This system
also includes signal analysis and display equipment, patient
and equipment support, components, and accessories.
The Philips Incisive CT has a 72cm bore and includes a
detector array that provides 50cm scan field of view (FOV). |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Besides installed in hospital, Philips Incisive CT can also
be installed on trailer and be transported to designated
locations. |
| | The main components (detection system, the reconstruction
algorithm, and the x-ray system) that are used in the
proposed Philips Incisive CT on trailer are identical to the
currently marketed and predicate Philips Incisive CT
(K180015, 20/March/2018). |
| | The components of the proposed Philips Incisive CT on
trailer include the following: |
| | 1. Gantry. The Gantry consists of 4 main internal units:
a. Stator – a fixed mechanical frame that carries HW and SW
b. Rotor – A rotating circular stiff frame that is mounted in
and supported by the stator
c. X-Ray Tube (XRT) and Generator, - fixed to the Rotor
frame |
| | d. Data Measurement System (DMS) - a detectors array,
fixed to the Rotor frame
2. Patient Support (Couch) - carries the patient in and out
through the Gantry bore synchronized with the scan.
3. Console - Containing a Host computer and display that is
the primary user interface. |
| | 4. CT on Trailer Kit - Modified Incisive CT installed and
secured on trailer requires locking motion parts during
trailer transportation and unlocking motion parts before
CT operations. |
| | In addition to the above components and the software
operating them, each system includes hardware and software
for data acquisition, display, manipulation, storage and |
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| Traditional 510(k) | |
|---|---|
| Indications for use: | filming as well as post-processing into views other than the |
| original axial images. Patient supports (positioning aids) are | |
| used to position the patient. | |
| The Incisive CT is a Computed Tomography X-Ray System | |
| intended to produce images of the head and body by | |
| computer reconstruction of x-ray transmission data taken at | |
| different angles and planes. These devices may include | |
| signal analysis and display equipment, patient and equipment | |
| supports, components and accessories. The Incisive CT is | |
| indicated for head, whole body, cardiac and vascular X-ray | |
| Computed Tomography applications in patients of all ages. | |
| These scanners are intended to be used for diagnostic | |
| imaging and for low dose CT lung cancer screening for the | |
| early detection of lung nodules that may represent cancer*. | |
| The screening must be performed within the established | |
| inclusion criteria of programs / protocols that have been | |
| approved and published by either a governmental body or | |
| professional medical society. | |
| Besides installed in hospital, the proposed Philips Incisive | |
| CT may also be installed on trailer and be transported to | |
| designated locations for use. And Incisive CT installed on | |
| trailer has the same intended use as installed in hospital. | |
| *Please refer to clinical literature, including the results of the | |
| National Lung Screening Trial (N Engl J Med 2011;365:395- |
- and subsequent literature, for further information. |
| Fundamental scientific
technology: | The proposed Philips Incisive CT on Trailer is advanced
continuous rotation computed tomography systems suitable
for a wide range of computed tomographic (CT)
applications. |
| | The proposed Philips Incisive CT on Trailer can be
transported by the trailer to designated locations and is used
clinically as a diagnostic patient imaging device that
produces images that correspond to tissue density. The
quality of the images depends on the level and amount of X-
ray energy delivered to the tissue. CT imaging displays both
high-density tissue, such as bone, and soft tissue. |
| | The principal technological components (rotating x-ray tube,
detector, gantry, patient support and console) of the proposed
Philips Incisive CT are identical to the currently marketed |
| | Traditional 510(k) |
| | predicate device Philips Incisive CT (K180015, 20/March/2018). |
| | In addition, the Proposed Philips Incisive CT on Trailer provides CT on trailer kit which is used to install and secure Philips Incisive CT (K180015, 20/March/2018) on a trailer. |
| | Based on the information provided above, the proposed Philips Incisive CT on Trailer does not raise different questions of safety and effectiveness compare to the currently marketed predicate device Philips Incisive CT (K180015, 20/March/2018). |
| Summary of Non-Clinical
Performance data: | The currently marketed Philips Incisive CT (K180015) complies with the following international and FDA Recognized Consensus standards:
• 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 60601-1:2005, MOD).
FDA/CDRH recognition number 19-4
• IEC 60601-1-2:2014, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
FDA/CDRH recognition number 19-8
• IEC 60601-1-3:2013 Medical electrical equipment -- Part 1-3: General requirements for basic safety - Collateral standard: Radiation protection in diagnostic X-ray equipment
FDA/CDRH recognition number 12-269
• IEC 60601-1-6:2013 Medical electrical equipment -- Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
FDA/CDRH recognition number 5-89
• IEC 60601-2-44:2012 Medical electrical equipment - Part 2-44: Particular requirements for the safety of X-ray equipment
FDA/CDRH recognition number 12-256
• IEC 62304:2015 Medical device software -- Software life cycle processes
FDA/CDRH recognition number 13-79
• IEC 62366:2014 Medical Device-Application of Usability Engineering of Medical Devices |
| • ISO14971 Medical devices – Application of risk
management to medical devices (Ed. 2.0, 2007)
FDA/CDRH recognition number 5-40 | |
| • NEMA XR 25-2010 Computed Tomography Dose Check
FDA/CDRH recognition number 12-225 | |
| • NEMA XR 28-2013 Supplemental Requirements for User
Information and System Function Related to Dose in CT
FDA/CDRH recognition number 12-287 | |
| • NEMA XR 29-2013 Standard Attributes on CT Equipment
Related to Dose Optimization and Management | |
| • Guidance for Industry and FDA Staff – Guidance for the
Content of Premarket Submissions for Software Contained
in Medical Devices (issued May 11, 2005, document number
337). | |
| • Guidance for Industry and FDA Staff – Content of
Premarket Submissions for Management of Cybersecurity in
Medical Devices (issued October 2, 2014) | |
| • Guidance for Industry and FDA Staff – Use of
International Standard ISO 10993-1, "Biological evaluation
of medical devices – Part 1: Evaluation and testing within a
risk management process" (issued June 16, 2016) | |
| • Guidance for Industry and FDA Staff – Information to
Support a Claim of Electromagnetic Compatibility (EMC) of
Electrically-Powered Medical Devices (issued July 11, 2016) | |
| Additionally, the Philips Incisive CT complies with
performance standards for Computed Tomography (CT)
Equipment and Laser products (21 CFR 1020.33 and 21 CFR
1040.10, respectively). | |
| The proposed Philips Incisive CT on Trailer is identical to
the currently marketed and predicate Philips Incisive CT
(K180015) with regards to intended use, design and
fundamental scientific technology except for trailer kit that is
utilized to securely mount the CT system on the trailer. The
trailer kit consists of locking mechanism that lock the gantry
and couch parts of the CT System to the trailer. | |
| With regards to transportation testing the proposed Philips
Incisive CT on Trailer complies with Department of
Defense Test Method Standard for Environmental
Engineering Considerations and Laboratory Tests (MIL-
STD-810F). Method 514.5: Composite wheeled vehicle | |
| | Traditional 510(k) |
| | vibration exposures, as described in the main body, Annex
A, Annex B and Annex C of this method.
Philips Incisive CT on Trailer has passed the vibration test
of 300 hours to simulate a 10 years or 120,690 kM lifetime
with QA test including MeanCT, Uniformity, Noise, Spatial
Resolution, Slice Thickness, Linearity and Low Contrast
Resolution.
The QA test process and acceptance criteria are same as the
predicate device, this can demonstrate the Philips Incisive |
| | CT on Trailer performs as well as the predicate device. |
| Summary of Clinical
Data: | Clinical data is not warranted to demonstrate safety and
effectiveness of the proposed Philips Incisive CT on
Trailer since its design, intended use and fundamental
scientific technology is identical to the currently marketed
and predicate Philips Incisive CT (K180015,
20/March/2018). |
| Substantial Equivalence
Conclusion: | The design, intended use, fundamental scientific technology
and principal technological components (Tube, Generator,
Detector, gantry, patient support and console) of the
proposed Philips Incisive CT on Trailer are identical to the
currently marketed predicate Philips Incisive CT (K180015,
20/March/2018) except for the addition of a trailer Kit to
secure the CT System in a trailer. |
| | Based on the information provided above, the proposed
Philips Incisive CT on Trailer does not raise different
questions of safety and effectiveness as compared to the
currently marketed predicate Philips Incisive CT (K180015,
20/March/2018). The proposed Philips Incisive CT on
Trailer is therefore substantially equivalent to the currently
marketed and predicate Philips Incisive CT (K180015,
20/March/2018). |
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Image /page/8/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The letters are evenly spaced and fill most of the frame. The background is white, providing a strong contrast to the blue text.