(45 days)
No
The summary describes a standard digital mobile X-ray system and does not mention any AI or ML capabilities for image processing, analysis, or other functions.
No
The device is used for general X-ray imaging, which is a diagnostic procedure, not a therapeutic one.
No.
The device is described as a mobile radiographic system used for general X-ray imaging to "take x-ray images" and "generate, process and handle digital X-ray images." It is an imaging device, not a diagnostic device, as it produces images rather than interpreting them or providing a diagnosis.
No
The device description explicitly states that the MobileDiagnost M50 consists of a "mobile base unit and a user interface combined with a flat solid state X-ray detector," indicating it is a hardware system with integrated software for image generation, processing, and handling.
Based on the provided information, the MobileDiagnost M50 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- MobileDiagnost M50 Function: The MobileDiagnost M50 is a mobile radiographic system that uses X-rays to create images of the internal structures of the body. It does not analyze biological specimens.
The description clearly states its purpose is for "general X-ray imaging" of patients who cannot be moved to a fixed system, focusing on anatomical sites like the chest, extremities, spine, skull, and abdomen. This is a form of medical imaging, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The MobileDiagnost M50 is a mobile radiographic system used for general X-ray imaging. This system can be used for taking x-ray images of patients who can't be moved to a fixed system. Applications include examinations of chest, upper and lower extremities, spinal column, skull radiography and abdominal cavities. MobileDiagnost M50 is not suitable for Mammography.
Product codes
IZL, MOB
Device Description
The MobileDiagnost M50 is a digital mobile X-ray system, used to perform X-ray examinations in different locations of a hospital, particularly for the patient who cannot be transferred to a fixed X-ray room. The MobileDiagnost M50 allows the user to take X-rays on a digital wireless detector and the image can then be viewed on the Eleva Workspot.
The MobileDiagnost M50 consists of a mobile base unit and a user interface combined with a flat solid state X-ray detector. It is used by the operator to generate, process and handle digital X-ray images.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray imaging
Anatomical Site
chest, upper and lower extremities, spinal column, skull, abdominal cavities
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Used for patients who can't be moved to a fixed system, implying hospital or clinical settings where patients may have limited mobility.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical verification and validation tests have been performed with regards to the intended use, the technical claims, requirement specifications, and the risk management results.
Non-clinical verification and validation test results demonstrate that the MobileDiagnost M50:
- Complies with the aforementioned international and FDArecognized consensus standards and FDA guidance documents.
- Meets the acceptance criteria and is adequate for its intended use.
The MobileDiagnost M50 did not require a clinical study since substantial equivalence to the currently marketed and predicate MobileDiagnost wDR 2.0 was demonstrated with the following attributes:
- Design features;
- Indication for use;
- Fundamental scientific technology;
- Non-clinical performance testing including validation; and
- Safety and effectiveness.
Furthermore, the MobileDiagnost M50 employs an already cleared wireless detector by Varian Medical Systems (Varian PaxScan 4336Wv4 of the reference device, Varian Nexus DRTM Digital X-ray Imaging System - K161459, cleared on 09/06/2016); therefore a clinical image study is not required.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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.
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November 16, 2017
Image /page/0/Picture/1 description: The image shows 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.
Philips India Limited % Nidhi Bathwal Regulatory Operations Specialist Plot No. B-79, MIDC, Phase II, Chakan, Taluka-Khed. Village - Savardari Pune, Maharashtra 410501 INDIA
Re: K173187
Trade/Device Name: MobileDiagnost M50 Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: II Product Code: IZL, MOB Dated: October 18, 2017 Received: October 19, 2017
Dear Nidhi Bathwal:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Robert Odlo
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
MobileDiagnost M50
Indications for Use (Describe)
The MobileDiagnost M50 is a mobile radiographic system used for general X-ray imaging. This system can be used for taking x-ray images of patients who can't be moved to a fixed system. Applications include examinations of chest, upper and lower extremities, spinal column, skull radiography and abdominal cavities. MobileDiagnost M50 is not suitable for Mammography.
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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7. 510(k) Summary
510(k) Summary of Safety and Effectiveness
This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR §807.92.
| Date Prepared: | September 29, 2017 | ||
|---|---|---|---|
| Manufacturer: | Philips India Limited | ||
| Plot No. B-79, MIDC, Phase-II, Chakan | |||
| Taluka - khed, Village - Savardari | |||
| District: Pune | |||
| Maharashtra 410501 | |||
| India | |||
| Establishment Registration Number: 3010685285 | |||
| Primary Contact | |||
| Person: | Nidhi Bathwal | ||
| Title: Regulatory Operations Specialist | |||
| Phone: 91-206635 7814 | |||
| E-mail: nidhi.bathwal@philips.com | |||
| Secondary | |||
| Contact Person | Karthik Hoskere | ||
| Title: Regulatory Operations Specialist | |||
| Phone: 91-206635 7814 | |||
| E-mail: karthik.hoskere@philips.com | |||
| Device Name: | MobileDiagnost M50 | ||
| Classification: | Classification Name: | Mobile X-ray system | |
| Classification Regulation: | 21CFR 892.1720 | ||
| Classification Panel: | 90 – Radiology | ||
| Device Class: | Class II | ||
| Primary Product Code: | IZL | ||
| Secondary Product Code: | MOB |
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| Primary
| Predicate Device: | Trade Name: | MobileDiagnost wDR 2.0 |
|---|---|---|
| Manufacturer: | SEDECAL SA | |
| 510(k) Clearance: | K141895 (September 18, 2014) | |
| Classification Regulation: | 21 CFR, Part 892.1720 | |
| Classification Name: | Mobile X-Ray System | |
| Classification Panel: | 90 - Radiology | |
| Device Class: | Class II | |
| Primary Product Code: | IZL | |
| Secondary Product Code: | MQB | |
| Reference Device: | Trade Name: | Nexus DR™ Digital X-ray Imaging |
| System (with PaxScan 4336Wv4) | ||
| Manufacturer: | Varian Medical Systems | |
| 510(k) Clearance: | K161459 (September 6, 2016) | |
| Classification Regulation: | 21 CFR 892.1680 | |
| Classification Name: | Stationary X-ray system | |
| Classification Panel: | Radiology | |
| Device Class: | Class II | |
| Product Code: | MQB | |
| Reference Device: | Trade Name: | Eleva Workspot with SkyFlow |
| Manufacturer: | Philips Medical Systems | |
| 510(k) Clearance: | K153318 (December 22, 2015) | |
| Classification Regulation: | 21 CFR 892.1680 | |
| Classification Name: | Solid State X-ray Imager (Flat | |
| Panel/Digital Imager) | ||
| Classification Panel: | 90 - Radiology | |
| Device Class: | Class II | |
| Product Code: | MQB | |
| Secondary Product Code: | LLZ |
Device Description:
The MobileDiagnost M50 is a digital mobile X-ray system, used to perform X-ray examinations in different locations of a hospital,
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particularly for the patient who cannot be transferred to a fixed X-ray room. The MobileDiagnost M50 allows the user to take X-rays on a digital wireless detector and the image can then be viewed on the Eleva Workspot.
The MobileDiagnost M50 consists of a mobile base unit and a user interface combined with a flat solid state X-ray detector. It is used by the operator to generate, process and handle digital X-ray images.
The MobileDiagnost M50 is a mobile radiographic system used for Indications for general X-ray imaging. This system can be used for taking x-ray images Use: of patients who can't be moved to a fixed system. Applications include examinations of chest, upper and lower extremities, spinal column, skull radiography and abdominal cavities. MobileDiagnost M50 is not suitable for Mammography.
Fundamental The MobileDiagnost M50 employs the same basic construction and Scientific fundamental scientific technology as the currently marketed and predicate Technology: MobileDiagnost wDR 2.0 (K141895), with regards to the functionality of the following components: high-voltage generator, dual-focus rotation anode X-Ray tube, manual beam limiting device, digital wireless detector, and workstation for post-processing, storage and viewing images (see the comparison table comparing the MobileDiagnost M50 to the currently marketed and predicate MobileDiagnost wDR 2.0 provided below).
The outcome of this comparison demonstrates that the minor differences in the technological characteristics do not affect the safety or effectiveness of the MobileDiagnost M50 when compared to the currently marketed and predicate MobileDiagnost wDR 2.0.
The wireless portable detector of the MobileDiagnost M50 is identical to the wireless portable detector (PaxScan 4336Wv4) of the currently marketed and reference device, Varian Nexus DRTM Digital X-ray Imaging System manufactured by Varian Medical System (K161459, cleared Sept 6, 2016). Therefore, both the wireless portable detector of the MobileDiagnost M50 and the wireless portable detector of the reference device, Varian Nexus DR"M Digital X-ray Imaging System employ identical fundamental scientific technology.
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| Summary of Technological Characteristics of the MobileDiagnost M50 to the
| Currently Marketed and Predicate Device | |||
|---|---|---|---|
| Feature | Currently Marketed and | ||
| Predicate | |||
| MobileDiagnost wDR | |||
| 2.0 | |||
| (K141895) | Proposed | ||
| MobileDiagnost | |||
| M50 | Discussion | ||
| Basic Information | |||
| Base Unit | |||
| Type | Mobile X-ray unit with | ||
| wireless detector | Same | No difference; thus, | |
| demonstrating SE. | |||
| Dimensions: | |||
| (l x w x h) | |||
| In operation | |||
| max. | 2550 mm x 670 mm x | ||
| 2125 mm | 1836 mm x 618 mm | ||
| 2293 mm | The minor differences in | ||
| the dimensions do not | |||
| impact the safety or | |||
| effectiveness of the | |||
| device. Thus, | |||
| demonstrating SE. | |||
| Dimensions: | |||
| (l x w x h) | |||
| In transport | 1375 mm x 670 mm x | ||
| 1980 mm | 1371 mm x 618 mm | ||
| x 1500 mm | The minor differences in | ||
| the dimensions do not | |||
| impact the safety or | |||
| effectiveness of the | |||
| device. Thus, | |||
| demonstrating SE. | |||
| Dimensions: | |||
| Source - | |||
| floor distance | 550 mm to 2020 mm | 416 mm to 2056 | |
| mm | The minor differences in | ||
| the dimensions do not | |||
| impact the safety or | |||
| effectiveness of the | |||
| device. Thus, | |||
| demonstrating SE. | |||
| Mono bloc | |||
| rotation | |||
| around arm | |||
| axis | +/-180° | Same | No difference; thus, |
| demonstrating SE. | |||
| Mono bloc | |||
| rotation | |||
| around its | |||
| axis | +90° to -30° | +102° to -49° | The minor differences in |
| the rotation around the | |||
| axis do not impact the | |||
| safety or effectiveness of | |||
| the device. Thus, | |||
| demonstrating SE. | |||
| Mains | |||
| Supply | 100 VAC/110 VAC/230 | ||
| VAC±10% | |||
| 50 Hz/60 Hz | 98-120VAC/ 195- | ||
| 240VAC, | |||
| 50 Hz /60 Hz | The minor differences in | ||
| the mains supply do not | |||
| impact the safety or | |||
| effectiveness of the | |||
| device. Thus, | |||
| demonstrating SE. | |||
| Mode of | |||
| Releasing | |||
| Exposure | Releasing Exposure via | ||
| Hand switch or via | |||
| Remote Control | |||
| (Optional) | Same | No difference; thus, | |
| demonstrating SE. | |||
| Available | |||
| exposure | |||
| methods | Free exposure technique | ||
| on film cassettes or CR | |||
| systems | Same | No difference; thus, | |
| demonstrating SE. | |||
| Detector | |||
| Type | Digital wireless flat | ||
| detector | Same | No difference; thus, | |
| demonstrating SE. | |||
| Scintillator | Cesium Iodide | Gadox | The proposed |
| MobileDiagnost M50 | |||
| uses the same wireless | |||
| detector as in the | |||
| Detector size | Large detector: | ||
| 14" x 17" | |||
| Small detector: | |||
| 12" x 10" | Same: Large | ||
| detector: 14" x 17" | reference device: Nexus | ||
| DR™ Digital X-ray | |||
| Imaging System (with | |||
| PaxScan 4336Wv4) | |||
| (K161459), therefore | |||
| there is no impact on | |||
| safety and effectiveness. | |||
| Thus, demonstrating SE. | |||
| No difference; thus, | |||
| demonstrating SE. | |||
| Active area | Large detector: | ||
| 13.6" x 16.6" | |||
| Small detector: | |||
| 8.7" x 11.2" | Large detector: | ||
| 13.4" x 16.7" | The proposed | ||
| MobileDiagnost M50 | |||
| uses the same wireless | |||
| detector as in the | |||
| reference device: Nexus | |||
| DR™ Digital X-ray | |||
| Imaging System (with | |||
| PaxScan 4336Wv4) | |||
| (K161459), therefore | |||
| there is no impact on | |||
| safety and effectiveness. | |||
| Thus, demonstrating SE. | |||
| Image matrix | |||
| size | Large detector: | ||
| 2330 x 2846 pixels | |||
| Small detector: | |||
| 1500 x 1920 pixels | Large detector: | ||
| 2476 x 3072 pixels | The proposed | ||
| MobileDiagnost M50 | |||
| uses the same wireless | |||
| detector as in the | |||
| reference device: Nexus | |||
| DR™ Digital X-ray | |||
| Imaging System (with | |||
| PaxScan 4336Wv4) | |||
| (K161459), therefore | |||
| there is no impact on | |||
| safety and effectiveness. | |||
| Thus, demonstrating SE. | |||
| Pixel size | 148 µm | 139 µm | The proposed |
| MobileDiagnost M50 | |||
| uses the same wireless | |||
| detector as in the | |||
| reference device: Nexus | |||
| DR™ Digital X-ray | |||
| Imaging System (with | |||
| PaxScan 4336Wv4) | |||
| (K161459), therefore | |||
| there is no impact on | |||
| safety and effectiveness. | |||
| Thus, demonstrating SE. | |||
| Analog / | |||
| Digital (A/D) | |||
| conversion | 16 bits | Same | No difference; thus, |
| demonstrating SE. | |||
| Image | |||
| resolution | 3.38 lp/mm | 3.6 lp/mm | The proposed |
| MobileDiagnost M50 | |||
| uses the same wireless | |||
| detector as in the | |||
| reference device: Nexus | |||
| DR™ Digital X-ray | |||
| Imaging System (with | |||
| PaxScan 4336Wv4) | |||
| (K161459), therefore | |||
| there is no impact on | |||
| safety and effectiveness. | |||
| Thus, demonstrating SE. | |||
| Design Characteristics | |||
| X- Ray Tube | |||
| Type | TOSHIBA E7886X | X22 | The proposed |
| MobileDiagnost M50 X- | |||
| ray tube operates in the | |||
| same manner, therefore | |||
| there is no impact to | |||
| safety and effectiveness. | |||
| Thus, demonstrating SE. | |||
| Material | Rhenium-Tungsten, | ||
| Molybdenum | Same | No difference; thus, | |
| demonstrating SE. | |||
| Maximum | |||
| tube voltage | 150 kVp | 130 kVp | The minor differences in |
| the maximum tube | |||
| voltage does not impact | |||
| safety or effectiveness of | |||
| the device. Thus, | |||
| demonstrating SE. | |||
| Nominal | |||
| focal spot | 0.7/1.3 | 0.8 /1.3 | The minor difference in |
| the focal spot size does | |||
| not impact safety or | |||
| effectiveness of the | |||
| device. Thus, | |||
| demonstrating SE. | |||
| Anode type | Rotating | Same | No difference; thus, |
| demonstrating SE. | |||
| Nominal | |||
| anode input | |||
| power | 20kW, 40kW | 16kW, 32kW | The difference in the |
| nominal anode input | |||
| power does not impact | |||
| safety or effectiveness of | |||
| the device. Thus, | |||
| demonstrating SE. | |||
| Generator | |||
| Power | 20kW, 40kW | 16kW, 32kW | The minor difference in |
| the power does not | |||
| impact the safety or | |||
| effectiveness of the | |||
| device. Thus, | |||
| demonstrating SE. | |||
| Type | High frequency | Same | No difference; thus, |
| demonstrating SE. | |||
| kV range | 40 - 150 kV (1kV steps) | 40 - 125 kV (1kV | |
| steps) | The minor difference in | ||
| the maximum tube | |||
| voltage does not impact | |||
| the safety or | |||
| effectiveness of the | |||
| device. Thus, | |||
| demonstrating SE. | |||
| Milli ampere | |||
| sec | |||
| (mAs) range | 0.1 mAs - 500 mAs | 0.1 mAs - 110 mAs | The difference in the |
| mAs range does not | |||
| impact the safety or | |||
| effectiveness of the | |||
| device because the | |||
| required detector dose | |||
| can be achieved for all | |||
| clinical examinations for | |||
| the MobileDiagnost | |||
| M50. Therefore, there is | |||
| no impact on the safety | |||
| and effectiveness of the | |||
| device; thus, | |||
| demonstrating SE. | |||
| Collimator | |||
| Operation | |||
| mode | Manual with light field | ||
| indicator, multilayer, | |||
| squared field | Same | No difference; thus, | |
| demonstrating SE. | |||
| Shape of the | |||
| beam | Rectangular | Same | No difference; thus, |
| demonstrating SE. | |||
| External Connectivity | |||
| DICOM | DICOM compatible | Same | No difference; thus, |
| demonstrating SE. | |||
| Software Platform | |||
| Software | Philips Eleva Workspot | Same | The proposed |
| MobileDiagnost M50 | |||
| and the currently | |||
| marketed and predicate | |||
| Philips MobileDiagnost | |||
| wDR 2.0 both use the | |||
| same software platform, | |||
| the Philips Eleva | |||
| Workspot with SkyFlow | |||
| (K153318). Therefore, | |||
| there is no impact on the | |||
| safety and effectiveness | |||
| of the device; thus, | |||
| demonstrating SE. |
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Image /page/9/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The background is white, which makes the blue letters stand out.
Based on the information provided above, the MobileDiagnost M50 is considered substantially equivalent to the currently marketed and predicate MobileDiagnost wDR 2.0 (K141895, September 18, 2014) in terms of fundamental scientific technology.
| Summary of Non-Clinical
Performance
Data: | The MobileDiagnost M50 complies with the following International
and FDA-recognized consensus standards: ISO 14971, Application of risk management to medical devices IEC 60601-1, Medical Electrical Equipment – Part 1: General
requirements for basic safety and essential performance. IEC 60601-1-2, Medical electrical equipment – Part 1-2: General
requirements for basic safety and essential performance –
Collateral Standard: Electromagnetic Compatibility –
Requirements and tests IEC 60601-1-3, Medical Electrical Equipment Part 1-3: General
Requirements for Basic Safety and Essential Performance.-
Collateral Standard: Radiation Protection in Diagnostic X-Ray
Equipment. IEC 60601-1-6, Medical Electrical Equipment Part 1-6: General
Requirements for Basic Safety and Essential Performance-
Collateral Standard: Usability IEC 60601-2-54, Medical Electrical Equipment- Part 2-54:
Particular Requirements for the Basic Safety and Essential
Performance of X-Ray Equipment for Radiography and
Radioscopy |
| ------------------------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
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- IEC 62304, Medical Device Software Software Life Cycle ● Processes.
- IEC 62366, Medical devices - Application of Usability Engineering to Medical Devices.
- ISO 10993-1, Biological Evaluation of Medical Devices. ● Evaluation and Testing within a Risk Management Process
- ISO 13485, Quality management for medical devices
- CFR 1020.30 Diagnostic x-ray systems and their major components.
- CFR 1020.31 Radiographic equipment. ●
- Guidance Document, entitled "Guidance for the ● FDA Submission of 510(k)'s for Solid State X-ray Imaging Devices" issued September 1, 2016
- FDA Guidance Document entitled, "Guidance for the Content of ● Premarket Submissions for Software Contained in Medical Devices" issued May 11, 2005
- FDA Draft Guidance Document entitled, "Pediatric Information ● for X-ray Imaging Device Premarket Notifications" issued May 10, 2012
Non-clinical verification and validation tests have been performed with regards to the intended use, the technical claims, requirement specifications, and the risk management results.
Non-clinical verification and validation test results demonstrate that the MobileDiagnost M50:
- . Complies with the aforementioned international and FDArecognized consensus standards and FDA guidance documents.
- . Meets the acceptance criteria and is adequate for its intended use.
Therefore, the MobileDiagnost M50 is substantially equivalent to the currently marketed and predicate MobileDiagnost wDR 2.0 (K141895, September 18, 2014) in terms of safety and effectiveness.
Summary of Clinical Data:
The MobileDiagnost M50 did not require a clinical study since substantial equivalence to the currently marketed and predicate MobileDiagnost wDR 2.0 was demonstrated with the following attributes:
- Design features;
- Indication for use;
- Fundamental scientific technology; ●
- Non-clinical performance testing including validation; and ●
- Safety and effectiveness. ●
Furthermore, the MobileDiagnost M50 employs an already cleared wireless detector by Varian Medical Systems (Varian PaxScan 4336Wv4 of the reference device, Varian Nexus DRTM Digital X-ray Imaging
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System - K161459, cleared on 09/06/2016); therefore a clinical image study is not required.
Substantial The MobileDiagnost M50 is substantially equivalent to the currently marketed and predicate MobileDiagnost wDR 2.0 (K141895, September Equivalence Conclusion: 18, 2014) in terms of design features, fundamental scientific technology, indications for use, and safety and effectiveness.
Additionally, substantial equivalence was demonstrated with non-clinical performance (verification and validation) tests, which complied with the requirements specified in the international and FDA-recognized consensus standards, ISO 14971, IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-54, IEC 60601-1-6, IEC 62304, IEC 62366, and ISO 10993-1.
The results of these tests demonstrate that the MobileDiagnost M50 met the acceptance criteria and is adequate for its intended use.