(175 days)
The DigiX FDX radiographic systems are used in hospitals, clinics and medical practices. DigiX FDX enables radiographic exposure of the whole body including: Skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. It can also be used for intravenous, small interventions (like biopsy, punctures, etc.) and emergency (trauma critical ill) applications. Exposure may be taken with the Patient's sitting, standing, or in the prone position. The DigiX FDX System is not meant for mammography. The DigiX FDX uses an integrated or portable or fixed or wi-fi digital detector for generating diagnostic images by converting X-Ray into electronics signals. DigiX FDX is also designed to be used with conventional film/screen or Computed Radiography (CR) Cassettes.
The DigiX FDX system is a diagnostic x-ray system intended for general purpose radiographic imaging of the human body. It is not intended for mammographic imaging. The DigiX FDX system is comprised of a combination of devices that include a ceiling mounted x-ray tube suspension, vertical Bucky stand, fixed or mobile patient Bucky table, x-ray generator, x-ray tube, beam limiting device, and a solid-state image receptor. The DigiX FDX systems are not intended to be operated with any other cleared devices, or to be integrated with other software/hardware devices via direct or indirect connections.
Here's a summary of the acceptance criteria and the study information for the Allengers Medical Systems Limited DigiX FDX device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document primarily focuses on substantial equivalence to a predicate device (Siemens Ysio K081722) rather than defining explicit, quantitative acceptance criteria for clinical performance. The "acceptance criteria" can be inferred as meeting or being sufficiently similar to the predicate device in terms of functionality and safety, as well as complying with relevant standards.
| Acceptance Criteria (Inferred) | Reported Device Performance | Comments on Equivalence |
|---|---|---|
| Indications for Use: Essential equivalence in scope of use (skull, chest, abdomen, extremities, pediatric, adult, bariatric, interventions, emergency, not mammography). | Matches predicate. | Essentially the same. No differences in indication or intended use. |
| Mechanical System Travel (Ceiling-mounted X-ray tube suspension): Longitudinal, Transverse, Vertical travel within acceptable range for full patient coverage. | Longitudinal: 300 cm (Predicate: 346 cm) Transverse: 200 cm (Predicate: 220 cm) Vertical: 150 cm (Predicate: 190 cm) | Similar with less travel; provides full patient coverage. Does not affect safety or effectiveness. |
| Mechanical System Travel (Vertical Bucky Stand): Vertical travel within acceptable range for full patient coverage. | VBSAdv Vertical: 125 cm (Predicate: 145 cm) VBS M XL Vertical: 162 cm (Predicate: 141 cm) | Similar with less/more travel; provides full patient coverage. |
| Patient Table Features: Type, travel, locking mechanism, maximum patient capacity. | Matches predicate for several components: 4-way float top, electromagnetic locking. Different models (FloatexXL, Floatex+, Floatex, MobiT 6C, 4C, C) have varying travel limits and weight capacities. | Similar, providing patient positioning. Max patient capacity of 200 kg (440 lbs) lower than predicate's 300 kg (660 lbs) for some models, but "Does not affect safety or effectiveness." |
| X-ray Generator: Kilowatt rating, kV min/max, mA max @ 100kV, APR programming. | Matches predicate. | Same. |
| X-ray Tube: Focal spot sizes, heat units, target angle, target diameter, target material. | Variations in specific models (e.g., Varian G1092 vs. Siemens OPTITOP): - G1092: 0.6mm/1.2mm focal spot (Predicate: 0.6mm/1.0mm), 1 MHU (Predicate: 783 kHU), 108 mm target diameter (Predicate: 100 mm). G292: 0.6mm/1.2mm focal spot (Predicate: 0.6mm/1.0mm), 600 KHU (Same), 12° target angle (Predicate: 16°), 102 mm target diameter (Predicate: 100 mm). | Similar, providing essentially same imaging resolution and higher loading for some G1092 models. Different target angle for G292 provides full coverage at 40" SID. Differences in heat units and target diameter also noted as "similar" or providing higher loading/instantaneous focal spot loading. |
| Beam Limiting Device: Construction, compliance with CFR 21 1020.31, automatic feature. | Matches predicate. | Same. |
| Solid State X-ray Image Detectors: Panel type, active area, pixel pitch, pixel matrix, input scintillator, limiting resolution. | Detectors (e.g., P-E XRPAD 4343F vs. Trixell Pixium 4600): - Active area: 432x432mm (Predicate: 429x429mm). - Pixel pitch: 100 µm (Predicate: 143 µm). - Pixel matrix: 4318x4320 (Predicate: 3001x3001). - Limiting resolution: 5 lp/mm (Predicate: 3.57 lp/mm). Similar differences for other detector models listed. | Essentially the same imaging area. Provides higher resolution for pixel pitch, pixel matrix, and limiting resolution in most cases, which is considered an improvement and not negatively affecting safety or effectiveness. |
| Viewing Monitors: Size, resolution. | Matches predicate. | Same. |
| Software Features: DICOM 3.0 compatibility, operating system, user interaction, multi-user, image import/export, acquisition device, image interferences, organization, search, storage, database, viewing, measurement, annotation, operations, security, generator control. | Matches predicate for all listed software features. Also uses previously cleared image processing software. | Same. |
| Safety Standards Compliance: | Complies with 21 CFR 1020.30, 21 CFR 1020.31, IEC 60601-1, EN 60601-1-2, IEC 60601-1-3, IEC 60601-2-54, EN ISO 14971, EN 62366, EN 62304. | All applicable standards met. |
| Functional Performance: All system motions, image performance. | All functions met design requirements. Image performance criteria satisfactorily met (details in Section 18 of the original submission, not provided in this extract). | Confirmed. |
| Software/Firmware Functionality: All functions between DROC software and IntegraX firmware. | All functions passed testing criteria. | Confirmed. |
2. Sample Size Used for the Test Set and Data Provenance:
The document explicitly states: "It was determined that clinical evaluation was not required as all imaging devices have been previously cleared by the FDA."
Therefore, there was no clinical test set used for this specific 510(k) submission. The evaluation was based on non-clinical testing and substantial equivalence to previously cleared devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable, as no clinical test set requiring expert ground truth was used.
4. Adjudication Method for the Test Set:
Not applicable, as no clinical test set requiring adjudication was used.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. The device is a diagnostic X-ray system, not an AI-powered diagnostic tool, and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. The device is a diagnostic X-ray system, not an algorithm, and its performance is evaluated as a system used by a human operator.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable for clinical ground truth, as no clinical evaluation was performed. For non-clinical performance (image quality, functional testing, safety), the "ground truth" was compliance with design specifications and relevant international standards.
8. The sample size for the training set:
The document does not describe the use of machine learning or AI models that would require a "training set" in the traditional sense. The device is a traditional X-ray system. The component parts, such as solid-state detectors and image processing software, are stated to have been "previously cleared by the FDA" or "tested and evaluated per Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices." Therefore, any implicit training (e.g., for image processing algorithms) would have occurred as part of the development and clearance of those component devices, but details are not provided here for the system submission.
9. How the ground truth for the training set was established:
Not applicable, as no training set for an AI/ML model is described for this device.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or bird in flight, composed of three overlapping profiles.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 3, 2017
Allengers Medical Systems Limited % Manmohan Singh Deputy Manager, Regulatory Affairs Bhankharpur, Mubarakpur Road Derabassi, Distt Mohali, Punjab 140507 INDIA
Re: K162529
Trade/Device Name: DigiX FDX Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR Dated: September 9, 2016 Received: September 21, 2016
Dear Manmohan Singh:
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 (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); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
{1}------------------------------------------------
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael O'Hara
For
Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K162529
Device Name DigiX FDX
Indications for Use (Describe)
The DigiX FDX radiographic systems are used in hospitals, clinics and medical practices. DigiX FDX enables radiographic exposure of the whole body including: Skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. It can also be used for intravenous, small interventions (like biopsy, punctures, etc.) and emergency (trauma critical ill) applications.
Exposure may be taken with the Patient's sitting, standing, or in the prone position.
The DigiX FDX System is not meant for mammography.
The DigiX FDX uses an integrated or portable or fixed or wi-fi digital detector for generating diagnostic images by converting X-Ray into electronics signals. DigiX FDX is also designed to be used with conventional film/screen or Computed Radiography (CR) Cassettes.
Type of Use (Select one or both, as applicable)
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) SUMMARY K162529
| Company Name: Allengers Medical Systems Limited | |||
|---|---|---|---|
| Address: Bhankharpur, MubarakpurRoad, Derabassi, Distt Mohali-140507India | |||
| Telephone No: | +91-01762-662626,663602+919888014257 | ||
| Registration No .: | Not Applicable | ||
| Contact person: Manmohan Singh | |||
| Date Prepared: 1 September 2016 | |||
| Device (trade) name: DigiX FDX Digital Radiographic System | |||
| Common/usual name: Digital x-ray imaging system | |||
| Classification: CFR 21 892.1680 | |||
| Classification name: Stationary x-ray system | |||
| Classification Panel: | Radiology | ||
| Device Class: | Class II | ||
| Product Code: | 90 KPR |
Predicate device:
| Predicate device: | Siemens Ysio, (K081722) |
|---|---|
| Classification: | 21 CFR 892.1680 |
| Classification Name: | Stationary x-ray system |
| Common/usual name: | Digital x-ray imaging system |
| Device Class: | Class II |
| Product Code: | 90 KPR |
Secondary Predicate devices:
Allengers supplies digital detectors that have been previously cleared by the FDA or tested and evaluated per Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices.
Allengers utilizes image processing software that has been previously cleared by the FDA.
Allengers does not modify any software utilized for image processing or display.
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| Solid State Detectors | |
|---|---|
| Varian PaxScan 4343R – Fixed | K130318 |
| Varian PaxScan 4336R – Fixed | K130318 |
| Perkin Elmer XRPAD 4343F - Fixed | K142698 |
| Varian PaxScan 4336W – Wireless | K142049 |
| Perkin Elmer XRPAD 4336 – Wireless | K140551 |
| Image Processing Software | |
| e-COM Technology Ltd. DROC(Digital Radiography Operator Console) | K130883 |
Device description:
The DigiX FDX system is a diagnostic x-ray system intended for general purpose radiographic imaging of the human body. It is not intended for mammographic imaging.
The DigiX FDX system is comprised of a combination of devices that include a ceiling mounted x-ray tube suspension, vertical Bucky stand, fixed or mobile patient Bucky table, x-ray generator, x-ray tube, beam limiting device, and a solid-state image receptor.
The DigiX FDX systems are not intended to be operated with any other cleared devices, or to be integrated with other software/hardware devices via direct or indirect connections.
The following are the specific components for various configurations of the system. A complete system will consist of a selection of one of the devices in each category.
| Component | Manufacture | Model |
|---|---|---|
| Ceiling mounted x-ray tube suspension | Allengers | CSA Adv |
| Ceiling mounted x-ray tube suspension | Allengers | CSA FDX |
| Vertical Bucky Stand | Allengers | VBS Adv |
| Vertical Bucky Stand | Allengers | VBS M XL |
| Patient Table – Fixed | Allengers | Floatex+ |
| Patient Table - Fixed | Allengers | Floatex |
| Patient Table - Fixed | Allengers | Floatex XL |
| Patient Table - Mobile | Allengers | MobiT 6C |
| Patient Table - Mobile | Allengers | MobiT 4C |
| Patient Table - Mobile | Allengers | MobiT C |
| X-ray Generator | Allengers | XGEN-80R |
| X-ray Generator | Allengers | XGEN-65R |
| X-ray Tube | Varian | A192 |
| X-ray Tube | Varian | A292 |
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| X-ray Tube | Varian | G292 |
|---|---|---|
| X-ray Tube | Varian | G1092 |
| Beam Limiting Device | Ralco | R225 ACS |
| Solid State X-ray Image Detector – Fixed | Varian | PaxScan 4343R |
| Solid State X-ray Image Detector - Fixed | Varian | PaxScan 4336R |
| Solid State X-ray Image Detector - Fixed | Perkin Elmer | XRPAD 4343F |
| Solid State X-ray Image Detector - WiFi | Varian | PaxScan 4336W |
| Solid State X-ray Image Detector - WiFi | Perkin Elmer | XRPAD 4336 |
Indications for Use:
The DigiX FDX radiographic systems are used in hospitals, clinics and medical practices. DigiX FDX enables radiographic exposure of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. It can also be used for intravenous, small interventions (like biopsy, punctures, etc.) and emergency (trauma critical ill) applications. Exposure may be taken with the Patient's sitting, standing, or in the prone position. The DigiX FDX System is not meant for mammography.
The DigiX FDX uses an integrated (fixed) or portable wired/wireless detector for generating diagnostic images by converting X-Ray into electronics signals. DigiX FDX is also designed to be used with conventional film/screen or Computed Radiography (CR) Cassettes.
Technological Characteristics Comparison to Predicate Device:
The DigiX FDX system is a set of components similar to the Siemens Ysio X-ray System as compared in Table 12-1 found in Section 12, 510(k) Substantial Equivalence Comparison. This table below shows that the systems are either similar, or the same, as the predicate systems.
Software Features:
The software feature set and function is essentially the same as the Siemens Ysio, with both systems complying with DICOM 3.0 specifications. Refer to section 10. Software Features of the following table for a list of top level functions.
Substantial Equivalence:
The DigiX FDX radiographic x-ray system is substantially equivalent to the commercially available Siemens Ysio diagnostic x-ray system (K081722).
Functional and specification differences are identified in the following table:
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| Feature | DigiX FDX | PredicateSiemens Ysio | Same or Similarto predicate |
|---|---|---|---|
| 510(k) | K162529 | K081722 | |
| Indications forUse | The DigiX FDXradiographic systemsare used in hospitals,clinics and medicalpractices. DigiX FDXenables radiographicexposure of the wholebody including: skull,chest, abdomen, andextremities and maybe used on pediatric,adult and bariatricpatients. It can also beused for intravenous,small interventions(like biopsy,punctures, etc.) andemergency (traumacritical ill) applications.Exposure may betaken with thePatient's sitting,standing, or in theprone position.The DigiX FDXSystem is not meantfor mammography.The DigiX FDX usesan integrated (fixed) orportablewired/wirelessdetector for generatingdiagnostic images byconverting X-Ray intoelectronics signals.DigiX FDX is alsodesigned to be usedwith conventionalfilm/screen orComputedRadiography (CR)Cassettes. | The Ysio (New RAD-Family) systems arethe radiographicsystems used inhospitals, clinics, andmedical practices.Ysio enablesradiographic andtomographicexposures of thewhole body including:skull, chest, abdomen,and extremities andmay be used onpediatric, adult andbariatric patients. Itcan also be used forintravenous, smallinterventions (likebiopsy, punctures,etc.) and emergency(trauma, critical ill)applications.Exposures may betaken with the patientsitting, standing, or inthe prone position.The Ysio system is notmeant formammography.The Ysio uses anintegrated or portabledigital detector forgenerating diagnosticimages by convertingx-rays into electronicsignals. Ysio is alsodesigned to be usedwith conventionalfilm/screen orComputedRadiography (CR)Cassettes. | Essentially the SameNote:There are nodifferences betweenthe subject device andthe predicate withrespect to indicationand intended use. |
| Feature | DigiX FDX | PredicateSiemens Ysio | Same or Similarto predicate |
| 2. Ceiling mounted x-ray tube suspension | |||
| Model | CSAAdv & CSAFDX | Ysio | |
| Longitudinaltravel | 300 cm | 346 cm | Similar with less travel,provides full patientcoverage. Does notaffect safety oreffectiveness. |
| Transversetravel | 200 cm | 220 cm | Similar with less travel,provides full patientcoverage |
| Vertical travel | 150 cm | 190 cm | Similar with less travel,provides full patientcoverage |
| Tube rotation(horiz.) | ±180° | ±180° | Same |
| Tube rotation(vert.) | ±180° | ±180° | Same |
| Fully automated | Yes | Yes | Same |
| Digital Readout | Yes | Yes | Same |
| 3. Vertical Bucky Stand | |||
| Model | VBSAdv | BWS with Max static | |
| Vertical travel | 125 cm | 145 cm | Similar with less travel,provides full patientcoverage |
| Model | VBS M XL | BWS wi-D | |
| Vertical travel | 162 cm | 141 cm | Similar with more travel,provides full patientcoverage |
| 4. Patient Table | |||
| Model | FloatexXL | Bucky Table | |
| Type | 4-way float top | 4-way Float Top | Same |
| Longitudinaltravel | 95 cm, ±10 mm | N/A | Similar, provides patientpositioning. Does notaffect safety oreffectiveness. |
| Transversetravel | 25 cm, ±10 mm | N/A | Similar, provides patientpositioning. Does notaffect safety oreffectiveness. |
| Table top locking | Electromagnetic | Electromagnetic | Same |
| Feature | DigiX FDX | PredicateSiemens Ysio | Same or Similarto predicate |
| Maximum patientcapacity | 200 kg (440 lbs) | 300 kg (660 lbs) | Similar with lesscapacity. Does notaffect safety oreffectiveness. |
| Optional Model | Floatex+ | Bucky Table | N/A |
| Type | 6-way float top | 6-way float top | Same |
| Longitudinaltravel | 53.5 cm, ±10mm | N/A | N/A |
| Transversetravel | 18 cm, ±10mm | N/A | N/A |
| Vertical travel | 26.5 cm, ±10mm | 29 cm | Similar with less travel.Does not affect safetyor effectiveness. |
| Table top locking | Electromagnetic | Electromagnetic | Same |
| Maximum patientcapacity | 200 kg (440 lbs) | 300 kg (660 lbs) | Similar with lesscapacity. Does notaffect safety oreffectiveness. |
| Optional Model | Floatex | N/A | N/A |
| Type | 4-way floating top | N/A | N/A |
| Longitudinaltravel | 53.5 cm, ±10mm | N/A | N/A |
| Transversetravel | 20 cm, ±10mm | N/A | N/A |
| Table top locking | Electromagnetic | N/A | N/A |
| Maximum patientcapacity | 200 kg (440 lbs) | N/A | N/A |
| Optional Model | MobiT 6C | N/A | N/A |
| Type | Mobile with float top | N/A | N/A |
| Longitudinaltravel | 60 cm, ±10 mm | N/A | N/A |
| Transversetravel | 20 cm, ±10 mm | N/A | N/A |
| Vertical travel | 40 cm, ±10 mm | N/A | N/A |
| Table top locking | Electromagnetic | N/A | N/A |
| Maximum patientcapacity | 200 kg (440 lbs) | N/A | N/A |
| Feature | DigiX FDX | PredicateSiemens Ysio | Same or Similarto predicate |
| Optional Model | MobiT 4C | N/A | N/A |
| Type | Mobile with float top | N/A | N/A |
| Longitudinaltravel | 60 cm, ±10 mm | N/A | N/A |
| Transversetravel | 20 cm, ±10 mm | N/A | N/A |
| Table top locking | Electromagnetic | N/A | N/A |
| Maximum patientcapacity | 200 kg (440 lbs) | N/A | N/A |
| Optional Model | Mobit C | N/A | N/A |
| Type | Mobile | N/A | N/A |
| Table top | Fixed | N/A | N/A |
| Maximum patientcapacity | 200 kg (440 lbs) | N/A | N/A |
| 5. X-ray Generator | |||
| Kilowatt rating | 65 kW standard | 65 kW standard | Same |
| 80 kW optional | 80 kW optional | Same | |
| kV minimum(65/80) | 40/40 kV | 40/40 kV | Same |
| kV maximum(65/80) | 150/150 kV | 150/150 kV | Same |
| mA maximum @100kV(65/80) | 650/800 mA | 650/800 mA | Same |
| APRprogramming | Yes | Yes | Same |
| 6. X-ray Tube | |||
| Tube Type | Varian G1092 | Siemens OPTITOP | |
| Focal Spot sizes | 0.6mm / 1.2mm | 0.6mm / 1.0mm | SimilarProvides essentially thesame imagingresolution on both focalspots |
| Heat Units | 1 MHU | 783 kHU | SimilarG1092 higher loading |
| Target Angle | 12° | 12° | Same |
| Target Diameter | 108 mm | 100 mm | SimilarG1092 higher loading |
| Feature | DigiX FDX | PredicateSiemens Ysio | Same or Similarto predicate |
| Target Material | RTM | RTM | Same |
| Optional Tube | Varian G292 | Siemens OPTILIX | N/A |
| Focal Spot sizes | 0.6mm / 1.2mm | 0.6mm / 1.0mm | Small Focal Spot theSame.Large focal spotprovides essentially thesame imaging results. |
| Heat Units | 600 KHU | 600 KHU | Same |
| Target Angle | 12° | 16° | SimilarProvides full coverageat 40" SID |
| Target Diameter | 102 mm | 100 mm | SimilarProvides higherinstantaneous focalspot loading |
| Target Material | RTM | RTM | Same |
| Optional Tube | Varian A292 | N/A | N/A |
| Focal Spot sizes | 0.6mm / 1.2mm | N/A | N/A |
| Heat Units | 400 KHU | N/A | N/A |
| Target Angle | 12° | N/A | N/A |
| Target Diameter | 102 mm | N/A | N/A |
| Target Material | RTM | N/A | N/A |
| Optional Tube | Varian A192 | N/A | N/A |
| Focal Spot sizes | 0.6mm / 1.2mm | N/A | N/A |
| Heat Units | 400 KHU | N/A | N/A |
| Target Angle | 12° | N/A | N/A |
| Target Diameter | 102 mm | N/A | N/A |
| Target Material | RTM | N/A | N/A |
| 7. Beam Limiting Device | |||
| Construction | Multi-tier | Multi-leaf | Same |
| CFR 211020.31 | Compliant | Compliant | Same |
| Automatic | Yes | Yes | Same |
| 8. Solid State X-ray Image Detectors | |||
| Model | P-E XRPAD 4343F | Trixell Pixium 4600 | N/A |
| FDA Cleared | Yes, K142698 | Yes, K093066 | N/A |
| Panel Type | Thin Film Transistor, | Thin Film Transistor, | Same |
| Feature | DigiX FDX | PredicateSiemens Ysio | Same or Similarto predicate |
| a-Si, wired (integrated) | a-Si, wired (integrated) | ||
| Active area | 432 mm X 432 mm | 429 mm X 429 mm | Essentially the Sameimaging area |
| Pixel pitch | 100 μm | 143 μm | Similar, provides higherresolution |
| Pixel matrix | 4318 X 4320 | 3001 X 3001 | Similar, provides higherresolution |
| Input scintillator | Cesium Iodide | Cesium Iodide | Same |
| Limitingresolution | 5 lp/mm | 3.57 lp/mm | Similar, provides higherresolution |
| Model | P-E XRPAD 4336 | Thales Pixium 3543 | |
| FDA Cleared | Yes, K140551 | Yes, K093066 | |
| Panel Type | Thin Film Transistor, a-Si, wireless (portable) | Thin Film Transistor, a-Si, wireless (portable) | Same |
| Active Area | 355 mm X 432 mm | 342 mm X 432 mm | Essentially the Sameimaging area |
| Pixel pitch | 100 μm | 144 μm | Similar, provides higherresolution |
| Pixel matrix | 3556 X 4320 | 2372 X 3000 | Similar, provides higherresolution |
| Input scintillator | Cesium Iodide | Cesium Iodide | Same |
| Limitingresolution | 5 lp/mm | 3.57 lp/mm | Similar, provides higherresolution |
| Optional Model | Varian PaxScan 4343R | Trixell Pixium 4600 | |
| FDA Cleared | Yes, K130318 | Yes, K093066 | See Section 18-2 |
| Panel Type | Thin Film Transistor, a-Si, wired (integrated) | Thin Film Transistor,a-Si, wired (integrated) | Same |
| Active Area | 424 mm X 424 mm | 429 mm X 429 mm | Essentially the Sameimaging area |
| Pixel pitch | 139 μm | 143 μm | Similar, provides higherresolution |
| Pixel matrix | 3072 X 3072 | 3001 X 3001 | Similar, provides higherresolution |
| Input scintillator | Cesium Iodide | Cesium Iodide | Same |
| Limitingresolution | 3.6 lp/mm | 3.57 lp/mm | Similar, provides higherresolution |
| Optional Model | Varian PaxScan 4336R | Thales Pixium 3543 | Secondary Predicate |
| Feature | DigiX FDX | PredicateSiemens Ysio | Same or Similarto predicate |
| FDA Cleared | Yes, K130318 | Yes, K093066 | Same |
| Type | Thin Film Transistor, a-Si, wired(Ethernet)(Portable) | Thin Film Transistor, a-Si, wired(Ethernet)(portable) | Same |
| Active Area | 353mm X 424 mm | 342 mm X 432 mm | Essentially the Sameimaging area |
| Pixel pitch | 139 µm | 144 µm | Similar, provides higherresolution |
| Pixel matrix | 2560 X 3072 | 2372 X 3000 | Similar, provides higherresolution |
| Input scintillator | Cesium Iodide | Cesium Iodide | Same |
| Limitingresolution | 3.6 lp/mm | 3.57 lp/mm | Similar, provides higherresolution |
| Optional Model | Varian PaxScan4336W | Thales Pixium 3543 | Secondary Predicate |
| FDA Cleared | Yes, K142049 | Yes, K093066 | Same |
| Type | Thin Film Transistor, a-Si, wireless (portable) | Thin Film Transistor, a-Si, wireless (portable) | Same |
| Active Area | 353 mm X 424 mm | 342 mm X 432 mm | Similar, provides higherresolution |
| Pixel pitch | 139 µm | 144 µm | Similar, provides higherresolution |
| Pixel matrix | 2560 X 3072 | 2372 X 3000 | Essentially the Same |
| Input scintillator | Cesium Iodide | Cesium Iodide | Similar, provides higherresolution |
| Limitingresolution | 3.6 lp/mm | 3.57 lp/mm | Similar, provides higherresolution |
| 9. Viewing Monitors | |||
| Monitor | 19 inch MedicalMonitor(1280 X 1024) | 19 inch MedicalMonitor(1280 X 1024) | Same |
| 10. Software Features | |||
| Model | DROC | DelWorks DR System | Secondary Predicate |
| FDA Cleared | Yes, K130883 | Yes, K140825 | Same |
| OperatingSystem | Microsoft Windows 7 | Microsoft Windows 7 | Same |
| Network | Ethernet / Wifi | Ethernet / Wifi | Same |
| User | Mouse, Keyboard, | Mouse, Keyboard, | Same |
| Feature | DigiX FDX | PredicateSiemens Ysio | Same or Similarto predicate |
| interaction/input | Touch Monitor, | Touch Monitor, | |
| Multi-user | Available | Available | Same |
| Import/Exportimages | Yes | Yes | Same |
| Acquisitiondevice | ComputedRadiography DigitalX-ray Detector | ComputedRadiography DigitalX-ray Detector | Same |
| ImageInterferences | Detector dependent | Detector dependent | Same |
| ImageOrganization | YesPatientID/Name/Studyinstance UID PatientID/Name/Studyinstance UID | YesPatientID/Name/Studyinstance UID PatientID/Name/Studyinstance UID | Same |
| Image Searchavailable | Yes | Yes | Same |
| Image Storage | Yes | Yes | Same |
| Databasestorage | Yes | Yes | Same |
| DatabaseSoftware | MS-Access | MS-Access | Same |
| Image Viewing | Yes | Yes | Same |
| ImageMeasurement | Yes | Yes | Same |
| ImageAnnotation | Yes | Yes | Same |
| ImageOperations | Yes | Yes | Same |
| Same Security | Yes(Priority by User) | Yes(Priority by User) | Same |
| DICOM 3.0Compatibility | Yes | Yes | Same |
| GeneratorControl | Yes | Yes | Same |
| GeneratorControl Protocols | Generator dependent | Generator dependent | Same |
| Raw image DataProcessing | Yes | Yes | Same |
| Feature | DigiX FDX | PredicateSiemens Ysio | Same or Similarto predicate |
| Post image dataprocessing | Yes | Yes | Same |
| RIS codemanager | Yes | Yes | Same |
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5-0-7
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Non-Clinical and Clinical Testing:
Non-clinical testing included verification and validation testing, image evaluation, testing, and safety testing. All devices subject to CDRH performance standards are certified to comply with the standard by their respective manufacturers. Risk Analysis was performed on the entire system. It was determined that clinical evaluation was not required as all imaging devices have been previously cleared by the FDA.
Safety information:
- The Allengers Medical Systems Limited systems comply with the applicable 0 requirements of 21 CFR 1020.30 and 21 CFR 1020.31.
- o The Allengers Medical Systems Limited systems comply with the international safety standards:
- IEC 60601-1:2005+CORR.1:2006+CORR.2:2007+AM1:2012 o
- EN 60601-1-2:2007+AC:2010, o
- IEC 60601-1-3:2008+A1:2013 O
- IEC 60601-2-54:2009+A1:2015 O
- EN ISO 14971:2012 O
- EN 62366:2008 O
- EN 62304:2006/AC:2008 O
Performance Testing:
Performance testing included functional testing of all motions of the system(s) with respect to the design specifications. Image performance testing was conducted with the results shown in Section 18 of this submission. All functions met the design requirements and the image performance criteria satisfactorily.
Software Features and Testing:
Both the Allengers DigiX FDX and the Siemens Ysio provide DICOM 3.0 format output imaging with a similar operational feature set. Therefore, Allengers conducted Software/Firmware testing to verify all functions between the DROC software and the IntegraX firmware functioned as intended. The Firmware Verification Summary Report appears in Section 16-1 of this submission, and indicates that all functions passed the testing criteria.
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Substantial Equivalence Discussion:
The Allengers Medical Systems Limited systems perform the same functions as the Siemens Ysio system utilizing the same technology. The operator interface functions are essential equivalent. All imaging procedures are conducted essentially the same on both systems.
Substantial Equivalence Conclusion:
The Allengers Medical Systems Limited systems do not introduce any new indications for use, nor does the use of the systems result in any new potential hazards. Allengers Medical Systems Limited considers the DigiX FDX diagnostic x-ray systems to be substantially equivalent with the predicate devices with respect to safety and effectiveness.
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.