(90 days)
No
The summary describes a standard mobile X-ray system with digital imaging capabilities and wireless connectivity. There is no mention of AI, ML, or any features that would typically indicate the use of such technologies for image analysis, workflow optimization, or other functions. The focus is on image acquisition, transmission, and basic system functionality.
No
The device is described as being for "diagnostic procedures" and for "obtaining digital images," which points to diagnostic use rather than therapeutic intervention.
Yes
The device produces radiographic images, which are used to aid in diagnosis.
No
The device description clearly states it is a "motorized mobile x-ray system" and lists hardware components like a "Base Unit," "X-ray generator," and "integrated wireless flat panel detectors." While it utilizes software for image acquisition and transmission, it is fundamentally a hardware system with integrated software.
Based on the provided information, the Radiography 7000 M is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- The Radiography 7000 M is an X-ray system used for imaging the internal structures of the human body directly. It uses radiation to create images, not to analyze biological samples.
The intended use and device description clearly indicate that this is an imaging device for diagnostic procedures performed on the patient, not with samples from the patient.
N/A
Intended Use / 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.
Product codes
IZL
Device Description
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
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-Ray
Anatomical Site
skull, chest, spine, shoulders, pelvis, extremities, abdomen, and other body regions.
Indicated Patient Age Range
adult and pediatric patients
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
This 510(K) premarket notification includes non-clinical performance testing.
Tests were performed on the proposed Radiography 7000 M according to the following FDA recognized standards and guidance documents: IEC 60601-1 Ed. 3.2, IEC 60601-1-2 Ed. 4.1, IEC 60601-1-3 Ed. 2.2, IEC 60601-1-6 Ed. 3.2, IEC 62304 Ed. 1.1, IEC 62366-1 Ed. 1.1, IEC 60601-2-54 Ed. 2.0, IEC 60601-2-28 Ed. 3.0, ISO 14971:2019, ISO 10993-1, IEC 62220-1-3:2008 Ed. 1.0, IEC 60601-1-9:2007/AMD2:2020, NEMA PS 3.1 - 3.20 DICOM Set, Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices (Sept 1, 2016), Guidance for Content of Premarket Submissions for Device Software Functions (June 14, 2023), Guidance for Radio Frequency Wireless Technology in Medical Devices (Aug 14, 2013), FCC Rules and Regulations CFR 47, Part 15, Subpart B, Guidance for Pediatric Information for X-ray Imaging Device Premarket Notifications (Nov 2017), Guidance for Cybersecurity in Medical Devices (Sept 27, 2023).
Key results:
System Verification testing: Pass - System verification test activities substantiate that the system conforms to the system requirements.
Software verification testing: Pass - Software verification test activities substantiate that the software conforms to the requirements.
Risk control: Pass - System meets the defined risk control measures.
Cyber Security: Pass - Results demonstrate that the test complies with the Cybersecurity requirements.
No clinical data was submitted.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
MobileDiagnost wDR 2.2 (K191813 - August 2, 2019)
Reference Device(s)
SM-IV (K232185 August 21, 2023)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1720 Mobile x-ray system.
(a)
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.(b)
Classification. Class II.
0
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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) |
|---|
| ------------------------------------------------- |
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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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.
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| 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) | Proposed Device:
Radiography 7000 M
(K233678) | Discussion & Conclusion | |
| X ray tube assembly
around longitudinal
tube axis | +90° to -30° | 110°
120° (+90° to -30°) | No differences in
characteristics between
subject and predicate
device; Hence
demonstrating Substantial
Equivalence. | |
| Mains Supply | 100 VAC/110 VAC/230
VAC±10%
50 Hz/60 Hz | 100 – 240V (+/- 10%
included in the range)
50 Hz/60 Hz | No differences in
characteristics between
subject and predicate
device; Hence
demonstrating Substantial
Equivalence. | |
| Mode of Releasing
Exposure | Releasing Exposure via
Hand switch or via
Remote Control
(Optional) | Releasing Exposure via
Hand switch or via
Remote Control
(Optional) | No differences in
characteristics between
subject and predicate
device; Hence
demonstrating Substantial
Equivalence. | |
| Available Exposure
Methods | Free exposure
technique on film
cassettes or CR systems
and wireless
portable detectors | Free exposure
technique on film
cassettes or CR
systems and wireless
portable detectors | No differences in
characteristics between
subject and predicate
device; Hence
demonstrating Substantial
Equivalence. | |
| Dead-man handle | Dead-man handle
based on micro switch
mechanism | Dead-man handle with
Capacitive touch
technology | This difference does not
impact the safety or
effectiveness
of the device; Hence
demonstrating Substantial
Equivalence. | |
| Collision detection | From front | From front and
partially from side | This difference does not
impact the safety or
effectiveness
of the device; Hence
demonstrating Substantial
Equivalence. | |
| Detector | | | | |
| Type | Digital wireless flat
detector | Digital wireless flat
detector | 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) | Proposed Device:
Radiography 7000 M
(K233678) | Discussion & Conclusion | |
| Detector Models | SkyPlate Large (Trixell
3543EZ 1.2)
Skyplate Small (Trixell
2430EZ 1.2)
SkyPlate E large (Trixell
3543DR) | SkyPlate Large (Trixell
3543EZ 1.3)
Skyplate Small (Trixell
2430EZ 1.3)
SkyPlate E large (Trixell
3543DR) | The difference in the
subject device is
additional protection
provided for liquid and
dust ingression. This
difference does not
impact the safety or
effectiveness of the
device. Hence
demonstrating Substantial
Equivalence. | |
| Detector Size | Large: 384 x 460 x 15
mm
Small: 328 x 268 x 15
mm
SkyPlate E Large: 384.5
x 460.5 x 15 mm | Large: 386 x 460 x 16
mm
Small: 328 x 269 x 16
mm
SkyPlate E Large: 384 x
460.5 x 15 mm | Length and width of the
plastic body increased to
support bigger sealing
layers
This difference does not
impact the safety or
effectiveness of the
device. Hence
demonstrating Substantial
Equivalence. | |
| On/off connector unit | Image: Current module EZ1.2 | Image: On/off connector unit | Side view (Cut), improved
sealing: - Additional screw hole on
the opposite side for
homogenious fixation
over the whole area - Bigger screw head type to
better cover the holes. - New fixation screws are
self-locking.
This difference does not
impact the safety or
effectiveness of the
device. Hence
demonstrating Substantial
Equivalence. | |
| X-Ray Absorber | Csl Scintillator | Csl Scintillator | 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) | Proposed Device:
Radiography 7000 M
(K233678) | Discussion & Conclusion | |
| Installation type | Portable | Portable | No differences in
characteristics between
subject and predicate
device; Hence
demonstrating Substantial
Equivalence. | |
| Readout Mechanism | Thin Film Transistor | Thin Film Transistor | No differences in
characteristics between
subject and predicate
device; Hence
demonstrating Substantial
Equivalence. | |
| Maximum X- ray Dose
for
Linear Response | 50 µGy | 50 µGy | No differences in
characteristics between
subject and predicate
device; Hence
demonstrating Substantial
Equivalence. | |
| Maximum Usable Dose | 75 µGy | 75 µGy | No differences in
characteristics between
subject and predicate
device; Hence
demonstrating Substantial
Equivalence. | |
| Image Processing | Eleva Workstation | Eleva Workspot | No differences in
characteristics between
subject and predicate
device; Hence
demonstrating Substantial
Equivalence. | |
| Maximum Lifetime
Dose | 100 μGy | 100 μGy | No differences in
characteristics between
subject and predicate
device; Hence
demonstrating Substantial
Equivalence. | |
| Detector Weight | Max 3.1 kg including
battery | Max 3.1 kg including
battery | 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) | Proposed Device:
Radiography 7000 M
(K233678) | Discussion & Conclusion | |
| Image Size (X-ray field) | 345.0 mm x 426.0 mm | 345.0 mm x 426.0 mm | No differences in
characteristics between
subject and predicate
device; Hence
demonstrating Substantial
Equivalence. | |
| Pixel Size | 160 μm | 160 μm | No differences in
characteristics between
subject and predicate
device; Hence
demonstrating Substantial
Equivalence. | |
| lmage matrix size
(Number of pixels) | 2156 x 2653 pixels | 2156 x 2653 pixels | No differences in
characteristics between
subject and predicate
device; Hence
demonstrating Substantial
Equivalence. | |
| Nyquist Frequency | 3.38 lp/mm
3.125 lp/mm | 3.38 lp/mm
3.125 lp/mm | No differences in
characteristics between
subject and predicate
device; Hence
demonstrating Substantial
Equivalence. | |
| Modulation Transfer
Function (MTF), typical
values | SkyPlate (543EZ &
2430EZ)
0.5 lp/mm 81%
1 lp/mm 63%
1.5 lp/mm 47%
2.0 lp/mm 35%
2.5 lp/mm 26%
3.0 lp/mm 19%
(Nyquist)
SkyPlate E (3543DR)
0.5 lp/mm 80%
1 lp/mm 62%
1.5 lp/mm 47%
2.0 lp/mm 34%
2.5 lp/mm 25%
3.0 lp/mm 18%
(Nyquist) | SkyPlate (543EZ &
2430EZ)
0.5 lp/mm 81%
1 lp/mm 63%
1.5 lp/mm 47%
2.0 lp/mm 35%
2.5 lp/mm 26%
3.0 lp/mm 19%
(Nyquist)
SkyPlate E (3543DR)
0.5 lp/mm 80%
1 lp/mm 62%
1.5 lp/mm 47%
2.0 lp/mm 34%
2.5 lp/mm 25%
3.0 lp/mm 18%
(Nyquist) | 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) | Proposed Device:
Radiography 7000 M
(K233678) | Discussion & Conclusion | |
| Detective Quantum
Efficiency (DQE), typical
values | DQE at 2.0 µGy Lp/mm
%
0.05 70
1 51
2 42
3 22
3.125 18 (Nyquist) | DQE at 2.0 µGy Lp/mm
%
0.05 70
1 51
2 42
3 22(Nyquist) | No differences in
characteristics between
subject and predicate
device; Hence
demonstrating Substantial
Equivalence. | |
| ADC
Digitization | 16 Bit | 16 Bit | No differences in
characteristics between
subject and predicate
device; Hence
demonstrating Substantial
Equivalence. | |
| Signal to Electronic
Noise Ratio
(SENR) | Min 37 dB - typical:
42.8 dB (@ 1 µGy) | Min 38 dB - typical: 44
dB (@ 1 μGy)
Min 37 dB - typical:
42.8 dB (@ 1 µGy) | Similar; No impact to
safety or effectiveness of
the device; Hence
demonstrating Substantial
Equivalence | |
| Data Interface to
Workstation | AP to workspot: 1
GBit/s Ethernet
Detector Ethernet via
BUC: 100
Mbit/s Ethernet
Detector to AP: 150
Mbit/s WLAN (gross
transfer rate) | AP to workspot: 1
GBit/s Ethernet
Detector Ethernet via
BUC: 100
Mbit/s Ethernet
Detector to AP via
WLAN (Aruba 303
WAP):
5GHz - 867 Mbps
2.4GHz - 300 Mbps | This difference does not
impact the safety or
effectiveness of the
device. Hence
demonstrating Substantial
Equivalence. | |
| Grids | | | | |
| Type | Large Grids for SkyPlate
Large
(468 mm x 476 mm x
25mm)
Small Grid for SkyPlate
Small
(mm x 354 mm x 25 mm)
Large Grids for SkyPlate
E
(468 mm x 476 mm x 23
mm) | Large Grids for
SkyPlate Large
(468 mm x 476
mm x 25 mm)
Small Grid for SkyPlate
Small
(280 mm x 354
mm x 25 mm)
Large Grids for
SkyPlate E
(468 mm x 476
mmx 25 mm) | No differences in
characteristics between
subject and predicate
device; Hence
demonstrating Substantial
Equivalence. | |
| Design characteristics
X - Ray Tube | | | | |
| 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 | |
| Tube | E7886X used with 40kW
Generator
E7865X used with 20kW
Generator | XRR-3331 - 0.6/1.2 | Single tube configuration
to address both adult and
pediatric clinical use case.
Hence no impact on
clinical needs and safety
of the device; Hence
demonstrating substantial
equivalence. | |
| Material | Rhenium-Tungsten,
Molybdenum | Rhenium-Tungsten
faced Molybdenum | No differences in
characteristics between
subject and predicate
device; Hence
demonstrating Substantial
Equivalence. | |
| Maximum tube voltage | 150 kVp | 150 kVp | No differences in
characteristics between
subject and predicate
device; Hence
demonstrating Substantial
Equivalence. | |
| Nominal focal spot | E7886X- 0.7/1.3
E7865X- 0.3/1.0 | XRR-3331 - 0.6/1.2 | Single tube configuration
to address both adult and
pediatric clinical use case.
Hence no impact on
clinical needs and safety
of the device; Hence
demonstrating substantial
equivalence. | |
| Anode type | Rotating | Rotating | No differences in
characteristics between
subject and predicate
device; Hence
demonstrating Substantial
Equivalence. | |
| Nominal
anode input power | 20kW, 40kW | 20kW, 40kW | No differences in
characteristics between
subject and predicate
device; Hence
demonstrating Substantial
Equivalence. | |
| Generators | | | | |
| Power Configurations | 20kW and 40kW | 20kW and 40kW | No differences in
characteristics between | |
| 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 | |
| | | | subject and predicate
device; Hence
demonstrating Substantial
Equivalence. | |
| Column Configuration | Standard Column
Sliding Column | Standard Column
Sliding Column | No differences in
characteristics between
subject and predicate
device; Hence
demonstrating Substantial
Equivalence. | |
| Exposure @ zero
degree column position | Exposures are allowed
when the column is at 0
Degree | Exposures are allowed
when the column is at
0 Degree | No differences in
characteristics between
subject and predicate
device; Hence
demonstrating Substantial
Equivalence. | |
| Exposure during
Charging | Exposures are allowed
when the unit is
connected to mains
(Note: exposure energy
is drawn from
generator batteries and
not from mains) | Exposures are allowed
when the unit is
connected to mains
(Note: Exposure
energy is drawn from
super caps which are
powered by battery
and not from mains.) | No differences in
characteristics between
subject and predicate
device; Hence
demonstrating Substantial
Equivalence. | |
| Collimator | | | | |
| Operation mode | Manual with light field
indicator, multilayer,
squared field | Manual Collimator
with front and rear
side knobs | External Connectivity
This difference does not
impact safety or
effectiveness of the
device; Hence
demonstrating Substantial
Equivalence | |
| Collimator | Collimator with manual
filter selection and no
shutter position
tracking | Collimator with
motorized filters and
manual shutter
position tracking | This change will result in
automatic Software
calculation of DAP without
additional hardware
DAP device requirements.
This difference does 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 | |
| Shape of the beam | Rectangular | Rectangular | No differences in
characteristics between
subject and predicate
device; Hence
demonstrating Substantial
Equivalence. | |
| Handles on Collimator | Handles can be used to
move both Tube head
and Collimator | Handles can be used to
move both Tube head
and Collimator | No differences in
characteristics between
subject and predicate
device; Hence
demonstrating Substantial
Equivalence. | |
| External Connectivity | DICOM | DICOM compatible | DICOM compatible | No differences in
characteristics between
subject and predicate
device; Hence
demonstrating Substantial
Equivalence. |
| Software Platform | Application Software | Eleva Workspot Inc 41
with SkyFlow | Eleva Workspot Inc 43
with SkyFlow | Subject device software
loaded with additional
Features. This difference
does not impact the safety
or effectiveness of the
device. Hence
demonstrating Substantial
Equivalence. |
| | Image Processing
Algorithm | UNIQUE 2 | UNIQUE 2 | No differences in
characteristics between
subject and predicate
device; Hence
demonstrating Substantial
Equivalence. |
| | PC | Intel® Core™ i5 based
PC | Intel® Core™ i7 based
PC, with SSD for better
performance Place
holder for 5G module | This difference does not
impact the safety or
effectiveness of the
device. Hence
demonstrating Substantial
Equivalence. |
| | DAP | Hardware DAP support | E-DAP (Software DAP)
and Hardware DAP | This difference does not
impact the safety or
effectiveness of the
device. Hence |
| | 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 | |
| Indications For Use
(IFU) | Intended for use by a
qualified/trained doctor
or technologist on both
adult and pediatric
patients for taking
diagnostic radiographic
exposures for the skull,
spinal column, chest,
abdomen, extremities,
and other body parts.
Applications can be
performed with patient
sitting, standing, or
lying in the prone or
supine
positions.
Not for mammography. | 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. | effectiveness of the
device. Hence
demonstrating Substantial
Equivalence.
The wording: "patients
who are unable to be
transferred to the
stationary X-ray system"
has been newly added
into proposed device
Radiography 7000 M
Indication for Use
compared to the
predicate device
MobileDiagnost wDR
2.2. because both
proposed device
Radiography 7000 M and
predicate device
MobileDiagnost wDR 2.2
will be operated on
patient that cannot be
transferred to Fixed X-ray
system. This aims to
enhance user clarity and
user understanding. This
modification does not
alter the operational
similarity between
proposed device
Radiography 7000 M and
its predicate device
MobileDiagnost wDR 2.2,
both capable of operating
on non-transferrable
patients.
The inclusion of
"shoulders" and "pelvis"
in the documentation
signifies additional clarity
on its capabilities, but it is
essential to note that | |
| | Predicate Device:
MobileDiagnost
wDR 2.2 (K191813, SE
date on August 2, 2019) | Proposed Device:
Radiography 7000 M
(K233678) | Discussion & Conclusion | |
| | | | examples, not limitations.
The device can be applied
to various body parts
beyond those explicitly
mentioned. | |
| | | | Conclusion:
Based on the information
and comparison
presented above, it can be
concluded that the
Indications For Use of the
proposed device
Radiography 7000 M is
substantially equivalent to
the Indications For Use of
the currently marketed
and predicate device
MobileDiagnost wDR 2.2. | |
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Philips Medical Systems DMC GmbH
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The outcome of this comparison demonstrates that the modifications do not affect the safety or effectiveness of the proposed Radiography 7000 M when compared to the currently marketed and predicate MobileDiagnost wDR 2.2 (K191813 - August 2, 2019).
Summary of Non-Clinical and Clinical Performance Data:
This 510(K) premarket notification includes non-clinical performance testing.
Tests were performed on the proposed Radiography 7000 M according to the following FDA recognized standards and guidance documents: The verification and validation methods and acceptance criteria) used to evaluate the proposed Radiography 7000 M are the same as those used for the predicate device (K191813) and follow International and FDA recognized consensus standards and guidance documents applicable to this device type:
- . IEC 60601-1 Edition 3.2 2020-08 CONSOLIDATED VERSION, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (Recognition # 19-49)
- IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests (Recognition # 19-36)
- . IEC 60601-1-3 Edition 2.2 2021-01 CONSOLIDATED VERSION, Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment (Recognition # 12-336)
18
- . 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 (Recognition # 5-132)
- . IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION, Medical device software - Software life cycle processes (Recognition # 13-79)
- . IEC 62366-1 Edition 1.1 2020-06 CONSOLIDATED VERSION, Medical devices - Part 1: Application of usability engineering to medical devices (Recognition # 5-129)
- . IEC 60601-2-54 Edition 2.0 2022-09, Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy (Recognition # 12-348)
- . IEC 60601-2-28 Edition 3.0 2017-06: Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis Recognition # 12-309
- . ISO 14971:2019, Medical devices - Application of risk management to medical devices(Edition 3.0) Recognition # 5-125
- . ISO 10993-1, Fifth edition 2018-08, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (Recognition # 2-258)
- . IEC 62220-1-3:2008 Edition 1.0 2008-06, Medical electrical equipment - Characteristics of digital Xray imaging devices - Part 1-3: Determination of the detective quantum efficiency - Detectors used in dynamic imaging (Recognition # 12-214)
- . IEC 60601-1-9:2007/AMD2:2020 Medical electrical equipment - Part 1-9: General requirements for basic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design.
- NEMA PS 3.1 - 3.20 Digital Imaging And Communications In Medicine (DICOM) Set
- . Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices, issued September 1, 2016
- Guidance for Content of Premarket Submissions for Device Software Functions, Issued on June 14, 2023.
- Guidance for Radio Frequency Wireless Technology in Medical Devices, issued on: August 14, 2013
- FCC Rules and Regulations CFR 47, Part 15, Subpart B (10-1-21 Edition)
- . Guidance for Pediatric Information for X-ray Imaging Device Premarket Notifications, issued November 2017
- Guidance for Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions issued on September 27, 2023
The proposed device complies with the Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices. The solid-state imaging components including the detector in the proposed device have the same physical, functional, and operational characteristics as the predicate device (K191813). Also, other image chain components like X-ray tube and generator, which are used for exposure characteristics and clinical performance evaluation remain the same. Hence, all the features and characteristics potentially influencing image quality of the proposed are in accordance with FDA guidance document 'Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices, dated September 1, 2016'. Additionally, Image quality testing has been performed on the proposed device for the changes that are affecting the image quality.
The proposed device complies with the Guidance for Content of Premarket Submissions for Device Software Functions, Issued on June 14, 2023. The changes to the proposed device do not alter the intended use or the fundamental scientific technology when compared to the predicate device (K191813). The software for the
Philips Medical Systems DMC GmbH
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General Management: Dr. Florian Kuhn (Chair), Dieto Ropers, Registered Office: Hamburg, Register Court Hamburg, 66 HRB 77 839, Tax No.: 22/27/250/0688, VAT No.: DE813038453, Bank Details: AG, Hamburg, SWFT-BC: DRESDEF200, BAN: DE82200800000651928300
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proposed device has the Enhanced documentation level. The software verification testing has been conducted as per the documentation level.
The proposed device complies with the Guidance for Pediatric Information for X-ray Imaging Device Premarket Notifications, issued November 2017. The changes made to the proposed device do not affect the pediatric application. The indication for use of the proposed device is the same as the predicate device (K191813).
The proposed device complies with Guidance for Radio Frequency Wireless Technology in Medical Devices, issued August 14, 2013 and FCC Rules and Regulations CFR 47, Part 15, Subpart B (10-1-21 Edition). The verification testing has been conducted for the safety and efficacy of the wireless components.
The proposed device complies with the Guidance for Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions issued on September 27, 2023. A set of cybersecurity controls to assure proposed device's cybersecurity and maintain medical device functionality and safety are in place. Cybersecurity plan and risk document are prepared to assess the proposed device for the following:
- Identification of assets, threats, and vulnerabilities;
- . Assessment of the impact of threats and vulnerabilities on device functionality and end users/patients;
- Assessment of the likelihood of a threat and of a vulnerability being exploited;
- Determination of risk levels and suitable mitigation strategies;
- . Assessment of residual risk.
Refer Table 2 for the non-clinical testing that were performed on the proposed device. Test results demonstrate that the proposed Radiography 7000 M meets acceptance criteria and is adequate for its intended use. Risk assessment activities show that the risks are sufficiently mitigated.
General Management: Dr. Florian Kuhn (Chair), Dieto Ropers, Registered Office: Hamburg, Register Court Hamburg, 66 HRB 77 839, Tax No.: 22/27/250/00688, VAT No.: DE813038453, Bank Details: AG, Hamburg, SWIFT-BC: DRESDEFF200, BAN: DE82200800000651928300
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Table 2 Testing Summary for the changes on the proposed device
| Tests | Test results |
|---|---|
| System Verification testing | Pass |
| System verification test activities substantiate that the system | |
| conforms to the system requirements | |
| Software verification testing | Pass |
| Software verification test activities substantiate that the software | |
| conforms to the requirements | |
| Risk control | Pass |
| System meets the defined risk control measures | |
| Cyber Security | Pass |
| Results demonstrate that the | |
| test complies with the | |
| Cybersecurity requirements |
There is no clinical data submitted in this 510(k) Premarket notification.
Substantial Equivalence Conclusion:
The proposed device, Radiography 7000 M is substantially equivalent to the currently marketed and predicate device, (K191813) in terms of the design features, technological characteristics, indications for use, and safety and effectiveness.
Additionally, substantial equivalence was demonstrated with non-clinical performance tests and testing as per FDA-recognized consensus standards. The test results demonstrate that the device conforms to its specifications and is safe and effective for its intended use.