Who is the manufacturer of Radiography 7000 M?

Philips Medical Systems Dmc GmbH filed the 510(k) submission for Radiography 7000 M (K233678).

What is the FDA product code for Radiography 7000 M?

IZL. It is classified under 21 CFR 892.1720 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for Radiography 7000 M?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Radiography 7000 M?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Radiography 7000 M

Q: What are the predicate devices for Radiography 7000 M?

MobileDiagnost wDR 2.2 (K191813).

K233678 · Philips Medical Systems Dmc GmbH · IZL · Feb 14, 2024 · Radiology

Device Facts

Record ID	K233678
Device Name	Radiography 7000 M
Applicant	Philips Medical Systems Dmc GmbH
Product Code	IZL · Radiology
Decision Date	Feb 14, 2024
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1720
Device Class	Class 2
Attributes	Pediatric

Indications for Use

The Radiography 7000 M is intended for diagnostic procedures on both adult and pediatric patients who are unable to be transferred to the stationary X-ray system. It enables radiographic imaging of various body parts, including the skull, chest, spine, shoulders, pelvis, extremities, abdomen, and other body regions. The system allows for applications in different positions, such as sitting, standing, and lying in either a prone or supine position. However, it should be noted that the system is not suitable for mammography applications.

Device Story

Motorized mobile X-ray system; utilizes wireless flat panel detectors (SkyPlate family) for digital image acquisition; supports CR or traditional film cassettes as backup. System components include base unit (Sedecal SM-IV), wireless detectors, and Eleva Workspot 43.0. Used in clinical environments (e.g., ICU, trauma, OR) by physicians or technologists. Operates via battery power (Li-ion) with smart management; features motorized filters, manual shutter tracking, and electromagnetic brakes for head assembly. Images transmitted to PACS/RIS/HIS via wireless technology. Output viewed on 21.5" DICOM multi-touch main screen; assists clinicians in diagnostic decision-making for non-transferable patients. Includes RFID-based login and status light indicators.

Clinical Evidence

No clinical data submitted. Substantial equivalence supported by non-clinical performance testing, including system verification, software verification, risk control, and cybersecurity assessments, following FDA-recognized consensus standards (e.g., IEC 60601 series, ISO 14971, ISO 10993-1).

Technological Characteristics

Mobile X-ray system; 20kW or 40kW generator; Li-ion battery; wireless flat panel detectors (Csl scintillator, TFT readout); 21.5" DICOM multi-touch display; electromagnetic head assembly brakes; motorized collimator filters. Connectivity: 1Gbit/s Ethernet, WLAN (Aruba 303 WAP). Software: Eleva Workspot 43.0 with UNIQUE 2 image processing. Complies with IEC 60601-1, 60601-1-2, 60601-1-3, 60601-2-54, 62304, 62366-1, and ISO 14971.

Indications for Use

Indicated for adult and pediatric patients unable to be transferred to stationary X-ray systems. Enables radiographic imaging of skull, chest, spine, shoulders, pelvis, extremities, abdomen, and other body regions in sitting, standing, prone, or supine positions. Not for mammography.

Regulatory Classification

Identification

A mobile x-ray system is a transportable device system intended to be used to generate and control x-ray for diagnostic procedures. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

MobileDiagnost wDR 2.2 (K191813)

Reference Devices

SM-IV (K232185)

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 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. February 14, 2024 Philips Medical Systems DMC GmbH % Shalin Dave Head of Regulatory Affairs DXR Röntgenstraße 24 Hamburg, 22335 GERMANY ## Re: K233678 Trade/Device Name: Radiography 7000 M Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile X-Ray System Regulatory Class: Class II Product Code: IZL Dated: November 8, 2023 Received: November 16, 2023 ## Dear Shalin Dave: 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 (the 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 available 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. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). {1}------------------------------------------------ Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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, Lu Jiang 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K233678 Device Name Radiography 7000 M ## Indications for Use (Describe) The Radiography 7000 M is intended for diagnostic procedures on both adult and pediatric patients who are unable to be transferred to the stationary X-ray system. It enables radiographic imaging of various body parts, including the skull, chest, spine, shoulders, pelvis, extremities, abdomen, and other body regions. The system allows for applications in different positions, such as sitting, standing, and lying in either a prone or supine position. However, it should be noted that the system is not suitable for mammography applications. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| | <input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | |----------------------------------------------------------------------------------| | <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) | ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # PHILIPS Page 1 of 18 # 510(k) Summary of Safety and Effectiveness This 510(k) summary of safety and effectiveness is prepared in accordance with 21 CFR §807.92. | Preparation Date: | November 14th , 2023 | |----------------------------|---------------------------------------------------------------------------------------------------------------------------------| | 510(k) Owner: | Philips Medical Systems DMC GmbH Röntgenstrasse 24 22335 Hamburg GERMANY Establishment registration number: 3003768251 | | Primary Contact: | Shalin Dave Head of Regulatory Affairs DXR Phone: +31 (6) 4253260 E-mail: shalin.dave@philips.com | | Secondary Contact: | Ming Xiao Regulatory Affairs Manager Phone: +49(40) 34971-2306 E-mail: ming.xiao@philips.com | | Proposed Device | | | Device Name | Radiography 7000 M | | Legal Manufacturer | Philips Medical Systems DMC GmbH Röntgenstrasse 24 22335 Hamburg GERMANY | | Classification Name: | Mobile x-ray system | | Classification Regulation: | 892.1720 | | Classification Panel: | 90 - Radiology | | Device Class: | Class II | | Product Code: | IZL | | Predicate Device | | | Device Name | MobileDiagnost wDR 2.2 | | Legal Manufacturer | Philips Medical Systems DMC GmbH Röntgenstrasse 24 22335 Hamburg GERMANY | | Classification Name: | Mobile x-ray system | | Classification Regulation: | 892.1720 | | Classification Panel: | 90 - Radiology | | Device Class: | Class II | | Product Code: | IZL, MQB | | Reference Device # 1 | | | Device Name | SM-IV | | Legal Manufacturer | SEDECAL SA | ## Philips Medical Systems DMC GmbH {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the word "PHILIPS" in blue, with a horizontal line running through the middle of the letters. The font is bold and sans-serif. The letters are evenly spaced and the word is centered. C/ Pelava, 9 – 13, Pol. Ind. Río de Janeiro22335 Hamburg 28110 Algete, Madrid España (Spain) Tel.- +34 91 6280544 Fax.- +34 91 6280574 Mobile x-ray system 892.1720 90 – Radiology Class II IZL ## Device Description: Classification Name: Classification Panel: Device Class: Product Code: Classification Regulation: The Radiography 7000 M digital mobile will be a new motorized mobile x-ray system that will employ integrated wireless flat panel detectors of two different sizes (large and small) to obtain digital images in mobile environments; the system will also be able to utilize CR or traditional film cassettes in a back-up scenario. The system will primarily use wireless technology for image acquisition and the transmission of images to archive systems like PACS, as well as for the retrieval of patient and exam information from the radiology information system (RIS) or hospital information system (HIS). The system is available in the following configurations. - with 20 kW X-ray generator - with 40 kW X-ray generator The Radiography 7000 M system is an integrated system consisting of the following subsystems: - Base Unit ( Sedecal Mobile X-ray system SM-IV, cleared under K232185 August 21, 2023) - · SkyPlate Family of detectors (Wireless Portable Detectors) and their accessories - Eleva WorkSpot 43.0 The "Radiography 7000M" complies with the requirements specified in FDA's device specific guidance document entitled, "Guidance for the submission of 510(k) for solid state X-ray Imaging Device – September 1, 2016." Compliance with Sections I through VI, VIII and IX, which includes Table of contents, Scope, Purpose, Description, Regulatory Requirements, Non-Clinical Considerations, Labeling and Quality Assurance Program, of the FDA guidance document for the detectors is demonstrated in this submission. ## Indications for Use: The Radiography 7000 M is intended for diagnostic procedures on both adult and pediatric patients who are unable to be transferred to the stationary X-ray system. It enables radiographic imaging of various body parts, including the skull, chest, spine, shoulders, pelvis, extremities, abdomen, and other body regions. The system allows for applications in different positions, such as sitting, standing, and lying in either a prone or supine position. However, it should be noted that the system is not suitable for mammography applications. ## Fundamental Scientific Technology The proposed Radiography 7000 M is substantially equivalent to the manufacturer's legally marketed devices: . Predicate Device: MobileDiagnost wDR 2.2 (K191813 - August 2, 2019), Philips Medical Systems DMC A detailed comparison of the proposed and predicate device (K191813) is provided in Table 1. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the word "PHILIPS" in a bold, sans-serif font. The letters are all capitalized and are a bright blue color. The word is centered and takes up most of the frame. The background is white. | Table 1: Comparison of the design feature of the currently marketed and predicate MobileDiagnost wDR 2.2 versus the proposed Radiography 7000 M | | | | | |----------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Predicate Device: MobileDiagnost wDR 2.2 (K191813, SE date on August 2, 2019) | Proposed Device: Radiography 7000 M (K233678) | Discussion & Conclusion | | | Clinical characteristics | | | | | | Intended use | The MobileDiagnost wDR is suitable for all routine radiographic exams, including specialty areas such as intensive care, trauma, operating room, or pediatric work. Standard radiography procedures are, for example: - X-ray examinations of the skeleton including skull, chest, spine, pelvis, upper extremities, lower extremities, etc. - X-ray examinations of the lung - X-ray examinations of soft tissue such as abdomen | The Radiography 7000 M is intended for diagnostic procedures on both adult and pediatric patients who are unable to be transferred to the stationary X-ray system. It enables radiographic imaging of various body parts, including the skull, chest, spine, shoulders, pelvis, extremities, abdomen, and other body regions. The system allows for applications in different positions, such as sitting, standing, and lying in either a prone or supine position. However, it should be noted that the system is not suitable for mammography applications. | No difference in characteristics between products. Conclusion: Same | | | Site of the body | Whole Body | Whole Body | No difference in characteristics between products. Conclusion: Same | | | Population | Any type of patient | Any type of patient | No difference in characteristics between products. Conclusion: Same | | | Basic Information | | | | | | Table 1: Comparison of the design feature of the currently marketed and predicate MobileDiagnost WDR 2.2 versus the proposed Radiography 7000 M | | | | | | | Predicate Device: MobileDiagnost WDR 2.2 (K191813, SE date on August 2, 2019) | Proposed Device: Radiography 7000 M (K233678) | Discussion & Conclusion | | | Design | Image: MobileDiagnost WDR 2.2 | Image: Radiography 7000 M | This difference does not impact the safety or effectiveness of the device; Hence demonstrating Substantial Equivalence. | | | Configuration | Battery Operated Mobile | Battery Operated Mobile | No differences in characteristics between subject and predicate device; Hence demonstrating Substantial Equivalence. | | | Battery | Lead Acid | lithium-ion (Li-ion) with advanced battery management system | Li-Ion battery-based solution brings smart battery management/monitoring system with fast charging. No impact on clinical needs and safety of the device; Hence demonstrating substantial equivalence. | | | Weight | 580kg | 450 kg (992 lb) | This difference does not impact the safety or effectiveness of the device; Hence demonstrating Substantial Equivalence. | | | Dimensions: (I x w x h) In operation max. | 2577 mm x 670 mm x 2125 mm | 2670 mm x 540 mm x 2220 mm | The differences in the dimensions do not impact the safety or effectiveness of the device. Hence demonstrating Substantial Equivalence. | | | Dimensions: (I x w x h) In transport | 1382 mm x 670 mm x 1960 mm | 1340 mm x 540 mm x 1285 mm | The differences in the dimensions do not impact the safety or effectiveness of the device. Hence demonstrating Substantial Equivalence. | | | Table 1: Comparison of the design feature of the currently marketed and predicate MobileDiagnost wDR 2.2 versus the proposed Radiography 7000 M | | | | | | | Predicate Device: MobileDiagnost wDR 2.2 (K191813, SE date on August 2, 2019) | Proposed Device: Radiography 7000 M (K233678) | Discussion & Conclusion | | | Dimensions: Source - floor distance | 530 mm to 2020 mm | 530 mm to 2020 mm | No differences in characteristics between subject and predicate device; Hence demonstrating Substantial Equivalence. | | | Tube Head Display | Not Available | Available with touch screen - 8.4" | This difference does not impact the safety or effectiveness of the device; Hence demonstrating Substantial Equivalence. | | | Head-assembly movements | Friction based movements | Electromagnetic brakes for omnidirectional Head assembly movement handle with capacitive touch technology based | This difference does not impact the safety or effectiveness of the device; Hence demonstrating Substantial Equivalence. | | | Monitor (Main Screen) | Non DICOM Touch (single) screen - 17" | DICOM Multi-touch main screen - 21.5" | This difference does not impact the safety or effectiveness of the device; Hence demonstrating Substantial Equivalence. | | | Status Light Indicator | NA (Not Available) | Status Light Indicator on column assembly to indicate system ready for exposure | This difference does not impact the safety or effectiveness of the device; Hence demonstrating Substantial Equivalence. | | | Smart Power ON / Login | keypad based | Smart on/off using RFID | This difference does not impact the safety or effectiveness of the device; Hence demonstrating Substantial Equivalence. | | | X ray Tube assembly rotation around telescope arm axis | +/-180° | ±180° | No differences in characteristics between subject and predicate device; Hence demonstrating Substantial Equivalence. | | | Table 1: Comparison of the design feature of the currently marketed and predicate MobileDiagnost wDR 2.2 versus the proposed Radiography 7000 M | | | | | | | Predicate Device: MobileDiagnost wDR 2.2 (K191813, SE date on August 2, 2019)…

Radiography 7000 M

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Reference Devices

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