Philips CT 3500

K223311 · Philips Healthcare (Suzhou) Co., Ltd. · JAK · Dec 22, 2022 · Radiology

Device Facts

• Record ID: K223311
• Device Name: Philips CT 3500
• Applicant: Philips Healthcare (Suzhou) Co., Ltd.
• Product Code: JAK · Radiology
• Decision Date: Dec 22, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2
• Attributes: AI/ML, Pediatric

Intended Use

The Philips CT 3500 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 Philips CT 3500 is indicated for head, whole body, cardiac (Cardiac Calcium Scoring) 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.

Device Story

Philips CT 3500 is a whole-body CT system; utilizes continuously rotating X-ray tube, detectors, and gantry to acquire transmission data; reconstructs data into cross-sectional images. System includes signal analysis, display equipment, and patient support. Used in hospitals or mobile trailers; operated by trained healthcare professionals. Provides diagnostic imaging and low-dose lung cancer screening. Features include O-MAR (metal artifact reduction), DoseRight Index (automatic mAs modulation), 3D-DOM (3D dose modulation), and Precise Image (deep learning-based noise reduction). Output viewed by radiologists/clinicians on console monitors to support diagnostic decision-making and clinical interventions (e.g., biopsies). Benefits include optimized radiation dose, improved image quality, and automated workflow tools for patient positioning and scan planning.

Clinical Evidence

Bench testing only. No clinical data required. Substantial equivalence established through verification and validation testing, including compliance with international consensus standards (IEC 60601 series, ISO 14971, ISO 10993-1) and NEMA XR standards for dose reporting and access control.

Technological Characteristics

Whole-body CT system with 72cm bore; 32/64 slice capability. Components: X-ray tube, high-voltage generator, detector array (DMS), patient couch, and operator console. Connectivity: DICOM compliant. Software: Windows 10-based. Includes deep learning-based noise reduction (Precise Image) and iterative reconstruction (iDose4). Sterilization: Not applicable (non-invasive imaging).

Indications for Use

Indicated for head, whole body, cardiac (Cardiac Calcium Scoring), and vascular CT imaging in patients of all ages, including low-dose CT lung cancer screening for early detection of lung nodules.

Regulatory Classification

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.

Predicate Devices

• Philips Incisive CT (K212441, K211168)

Submission Summary (Full Text)

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February 8, 2023

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Philips Healthcare (Suzhou) Co., Ltd % Diana Xu Associated Regulatory Affairs Manager No.258, ZhongYuan Road, Suzhou Industrial Park Suzhou, Jiangsu 215024 CHINA

Re: K223311 Trade/Device Name: Philips CT 3500 Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: JAK

Dear Diana Xu:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated December 22th, 2023. Specifically, FDA is updating this SE Letter as an administrative correction because there was an inadvertent formatting error in the page header.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Lu Jiang, OHT8: Office of In Vitro Diagnostics, [phone], [e-mail].

Sincerely,

Lu Jiang

2023.02.08
10:03:27
-05'00'

Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

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December 22, 2022

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Philips Healthcare (Suzhou) Co., Ltd % Diana Xu Associated Regulatory Affairs Manager No.258, ZhongYuan Road, Suzhou Industrial Park Suzhou. Jiangsu 215024 CHINA

#### Re: K223311

Trade/Device Name: Philips CT 3500 Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-Ray System Regulatory Class: Class II Product Code: JAK Dated: October 27, 2022 Received: October 28, 2022

#### Dear Ms. Xu:

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

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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 medical devices and radiation-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 [phone] or 301-796-7100).

Sincerely,

2022.12.22
09:52:43
Lu Jiang
-05'00'

Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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#### Indications for Use

510(k) Number (if known)

K223311

Device Name Philips CT 3500

#### Indications for Use (Describe)

The Philips CT 3500 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 Philips CT 3500 is indicated for head, whole body, cardiac (Cardiac Calcium Scoring) 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.

*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) | |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <svg fill="none" height="16" viewbox="0 0 16 16" width="16" xmlns="http://www.w3.org/2000/svg"> <path d="M13.2222 3.77776L5.77778 11.2222L2.77778 8.22221" stroke="#000000" stroke-linecap="round" stroke-linejoin="round" stroke-width="1.5"></path> </svg> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <svg fill="none" height="16" viewbox="0 0 16 16" width="16" xmlns="http://www.w3.org/2000/svg"> <rect height="15" rx="2.5" stroke="#000000" width="15" x="0.5" y="0.5"></rect> </svg> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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Image /page/4/Picture/0 description: The image shows the word "PHILIPS" in a bold, sans-serif font. The word is written in a bright blue color. The letters are evenly spaced and the overall appearance is clean and modern.

#### 510(k) Summary of Safety and Effectiveness K223311

[As required by 21 CFR 807.92(c)]

| Date Prepared: | October 26, 2022 |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer: | Philips Healthcare (Suzhou) Co., Ltd.<br>No. 258, Zhongyuan Road, Suzhou Industrial Park,<br>Suzhou Jiangsu, CHINA, 215024<br>Establishment Registration Number: 3009529630 |
| Primary Contact<br>Person: | Diana Xu<br>Associated Regulatory Affairs Manager<br>Phone: [phone]<br>E-mail: [e-mail] |
| Secondary Contact<br>Person | Erhong Wang<br>Senior Manager Regulatory Affairs<br>Phone: [phone]<br>E-mail: [e-mail] |
| Device Name: | Philips CT 3500 |
| Classification: | Classification name: Computed tomography x-ray system<br>Classification Regulation: 21CFR 892.1750<br>Classification Panel: Radiology<br>Device Class: Class II<br>Primary Product Code: JAK |
| Predicate Device: | Trade name: Philips Incisive CT<br>Manufacturer: Philips Healthcare (Suzhou) Co., Ltd.<br>510(k) Clearance: K212441, K211168<br>Classification Regulation: 21CFR 892.1750<br>Classification name: Computed tomography x-ray system<br>Classification Panel: Radiology<br>Device class: Class II<br>Product Code: JAK |

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Device Description: The proposed Philips CT 3500 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 analvsis and display equipment, patient and equipment supports, components, and accessories. The Philips CT 3500 has a 72cm bore and includes a detector array that provides 50cm scan field of view (FOV). Besides installed in hospital, the proposed Philips CT 3500 may also be installed on trailer and be transported to designed locations for use. And Philips CT 3500 installed on trailer has the same intended use as installed in hospital. The key components that are used in the proposed Philips CT 3500 have the same fundamental design characteristics and are based on comparable technologies as the current market predicate Philips Incisive CT (K212441 - April 27, 2022). CT on Trailer Kit that is used in the proposed Philips CT 3500 to install and secure the CT system on trailers have the same fundamental design characteristics and are based on comparable technologies as the current market predicate Philips Incisive CT on trailer (K211168 - November 22, 2021). Trailers are provided by trailer manufactures and are not components of the proposed Philips CT 3500. The key system modules and functionalities are: 1. Gantry. The Gantry consists of 4 main internal units: a) X-Ray Tube – produce X-ray necessary for scanning. b) High voltage generator - produce high voltage power supply to X-ray tube. consists of system Interface Unit, Power Block Unit and Anode Drive Unit. c) A-plane: adjust the slice thickness during axial scan and monitors the changes of X-ray d) DMS (Data Measurement System) – absorb X-ray radiation by detectors and convert it to digital readout. 2. Patient Table (Couch)

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| | Couch is used to position the patient. Carries the patient in and out through the Gantry bore synchronized with the scan. |
|-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 3. Console |
| | It is used to operate the system and monitor the scan. The Operator console includes computer, monitor and CTBOX. |
| | 4. CT on Trailer Kit |
| | Philips CT 3500 installed and secured on trailer requires locking motion parts during trailer transportation and unlocking motion parts before CT operations. CT on Trailer Kit is used to install and secure the CT system on trailers, trailers are provided by trailer manufactures and are not components of the proposed Philips CT 3500. |
| | 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. |
| Indications for Use: | The Philips CT 3500 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 Philips CT 3500 is indicated for head, whole body, cardiac (Cardiac Calcium Scoring) 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. |
| | *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. |
| | |
| Fundamental<br>Scientific<br>Technology: | The proposed Philips CT 3500 is advanced continuous<br>rotation computed tomography systems suitable for a wide<br>range of computed tomographic (CT) applications. |
| | The proposed Philips CT 3500 is used clinically as a<br>diagnostic patient imaging device that produces images that<br>correspond to tissue density. The quality of the images<br>depends on the level and amount of X-ray energy delivered<br>to the tissue. CT imaging displays both high-density tissue,<br>such as bone, and soft tissue. |
| | The principal technological imaging chain components (x-<br>ray tube, high voltage generator and detector) of the<br>proposed Philips CT 3500 substantially equivalent to the<br>currently marketed predicate device Philips (K212441 -April<br>27, 2022; K211168 - November 22, 2021). |
| | Based on the information provided above, the proposed<br>Philips CT 3500 does not raise different questions of safety<br>and effectiveness compared to the currently marketed<br>predicate device (K212441 -April 27, 2022; K211168 -<br>November 22, 2021). |
| Summary of Non-Clinical Performance Data: | The proposed Philips CT 3500 comply 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 Edition 4.0 2014-02, 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 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 FDA/CDRH recognition number 12-269 IEC 60601-1-6 Edition 3.2 2020-07 CONSOLIDATED VERSION, Medical electrical equipment -- Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability FDA/CDRH recognition number 5-132 IEC 60601-2-44 Edition 3.2: 2016, Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography FDA/CDRH recognition number 12-302 IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION, Medical device software -- Software life cycle processes FDA/CDRH recognition number 13-79 IEC 62366-1 Edition 1.1 2020-06 CONSOLIDATED VERSION, Medical devices -- Part 1: Application of usability engineering to medical devices FDA/CDRH recognition number 5-129 |
| ● | ISO 14971 Third Edition 2019-12 Medical devices –<br>Application of risk management to medical devices<br>FDA/CDRH recognition number 5-125 |
| ● | ISO 10993-1 Fifth edition 2018-08 Biological evaluation<br>of medical devices - Part 1: Evaluation and testing<br>within a risk management process<br>FDA/CDRH recognition number 2-258 |
| ● | NEMA XR 25 -2019 Computed Tomography Dose<br>Check<br>FDA/CDRH recognition number 12-325 |
| ● | NEMA XR 26-2020 Access Controls for Computed<br>Tomography – Identification, Interlocks, and Logs |
| ● | NEMA XR 28-2013 Supplemental Requirements for<br>User Information and System Function Related to Dose<br>in CT<br>FDA/CDRH recognition number 12-287 |
| ● | NEMA XR 29-2013 Standard Attributes on CT<br>Equipment Related to Dose Optimization and<br>Management |
| ● | Guidance for Industry and FDA Staff – Guidance for the<br>Content of Premarket Submissions for Software<br>Contained in Medical Devices (issued May 11, 2005,<br>document number 337) |
| ● | Guidance for Industry and FDA Staff – Content of<br>Premarket Submissions for Management of<br>Cybersecurity in Medical Devices (issued October 2,<br>2014, document number 1825) |
| ● | Guidance for Industry and FDA Staff – Use of<br>International Standard ISO 10993-1, "Biological<br>evaluation of medical devices - Part 1: Evaluation and<br>testing within a risk management process" (issued<br>September 4, 2020, document number 1811-R1) |
| ● | Guidance for Industry and Food and Drug<br>Administration Staff - Electromagnetic Compatibility<br>(EMC) of Medical Devices: (issued June 6, 2022,<br>document number 1400057) |
| | The systems comply with industry guidance and<br>performance standards for Computed Tomography (CT)<br>Equipment and Laser products (21 CFR 1020.33 and 21<br>CFR 1040.10, respectively).<br>The systems performed a comparison to the predicate<br>device using these technological characteristics and image<br>quality metrics to establish that the subject device is<br>substantially equivalent to the predicate device for its<br>intended use. |
| | The systems pass the design verification, design validation<br>and consensus standards test as nonclinical tests. The<br>system verification is conducted against the system<br>requirement specifications (SRS). System verification<br>activities demonstrate the system meet the established<br>system design input requirements. System requirements<br>may be verified by manual test, automated test,<br>inspection/analysis, or any combination of the three. Non-<br>Clinical design validation testing covered the intended use<br>and commercial claims. Validation testing included workflow<br>validation. |
| | The test results demonstrate that the proposed Philips CT<br>3500 meets the acceptance criteria and is adequate for its<br>intended use. Additionally, the risk management activities<br>show that all risks are sufficiently mitigated, that no new<br>risks are introduced, and that the overall residual risks are<br>acceptable. |
| Summary of Clinical<br>Data: | The proposed Philips CT 3500 did not require clinical study<br>since substantial equivalence to the legally marketed<br>predicate device was proven with the verification/validation<br>testing. |

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#### Substantial Equivalence

| Installed Environment Comparison | | | |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Proposed Philips CT<br>3500 | Predicate Device<br>Philips Incisive CT<br>(K212441, K211168) | Conclusion |
| Installed<br>environment | In hospital, on trailer | In hospital, on trailer | Identical.<br>Therefore,<br>substantially<br>equivalent. |
| CT on Trailer | Besides installed in<br>hospital, the proposed<br>Philips CT 3500 may<br>also be installed on<br>trailer and be<br>transported to<br>designated locations for<br>use. And Philips CT<br>3500 installed on trailer<br>has the same intended<br>use as installed in<br>hospital.<br>The design, intended<br>use, fundamental<br>scientific technology<br>and principal<br>technological<br>components (Tube,<br>Generator, Detector,<br>gantry, patient table<br>and console) are same<br>as the proposed Philips<br>CT 3500 in hospital<br>except for the addition<br>of a CT on Trailer Kit to<br>secure the CT system<br>in a trailer.<br>CT on Trailer Kit<br>includes:<br>• Couch vertical lock<br>and horizontal lock<br>ASSY,<br>• UPS lock ASSY, | Besides installed in<br>hospital, the proposed<br>Philips Incisive CT may<br>also be installed on<br>trailer and be<br>transported to<br>designated locations for<br>use. And Incisive CT<br>installed on trailer has<br>the same intended use<br>as installed in hospital.<br>The design, intended<br>use, fundamental<br>scientific technology<br>and principal<br>technological<br>components (Tube,<br>Generator, Detector,<br>gantry, patient table<br>and console) are same<br>as the Philips Incisive<br>CT in hospital except<br>for the addition of a CT<br>on Trailer Kit to secure<br>the CT system in a<br>trailer.<br>CT on Trailer Kit<br>includes:<br>• Gantry tilt lock<br>ASSY,<br>• Couch vertical lock<br>ASSY,<br>• Couch horizontal<br>lock ASSY, | The proposed<br>Philips CT 3500<br>Gantry has no tilt<br>function. All motion<br>parts can be fixed<br>by on trailer kit.<br>The design,<br>intended use,<br>fundamental<br>scientific<br>technology and<br>principal<br>technological<br>components are<br>identical to the<br>predicate device.<br>Safety and<br>effectiveness are<br>not affected.<br>Therefore,<br>demonstrating<br>substantial<br>equivalence. |
| | Installed Environment Comparison | | |
| | Proposed Philips CT<br>3500 | Predicate Device<br>Philips Incisive CT<br>(K212441, K211168) | Conclusion |
| | • Isolation<br>Transformer lock<br>ASSY | • UPS lock Kits,<br>• Console fixation<br>device,<br>• Isolation<br>Transformer lock<br>Kits…