(175 days)
No
The document describes a standard digital radiography system and does not mention any AI or ML capabilities in its intended use, device description, or performance studies.
No
The device is described as a diagnostic x-ray system used for generating diagnostic images, not for treating any condition.
Yes
The "Intended Use / Indications for Use" section states that the device is "for generating diagnostic images." The "Device Description" also clearly labels it as a "diagnostic x-ray system."
No
The device description explicitly lists multiple hardware components (x-ray tube suspension, Bucky stand, table, generator, tube, beam limiting device, image receptor) and states it is a "diagnostic x-ray system," indicating it is a hardware-based device with integrated software.
Based on the provided text, the DigiX FDX radiographic system is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens taken from the human body. The text clearly states that the DigiX FDX system is used for "radiographic exposure of the whole body" and generates diagnostic images by converting X-Ray into electronic signals. This involves imaging the patient directly, not analyzing samples from the patient.
- The intended use and device description focus on imaging the human body using X-rays. There is no mention of analyzing blood, urine, tissue, or any other biological specimen.
Therefore, the DigiX FDX system falls under the category of medical imaging devices, not IVD devices.
N/A
Intended Use / 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 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.
Product codes (comma separated list FDA assigned to the subject device)
KPR
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.
Mentions image processing
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.
Raw image Data Processing: Yes
Post image data processing: Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-Ray
Anatomical Site
whole body including: Skull, chest, abdomen, and extremities
Indicated Patient Age Range
pediatric, adult and bariatric patients
Intended User / Care Setting
hospitals, clinics and medical practices.
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
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Siemens Ysio, (K081722)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K130318, K142698, K142049, K140551, K130883
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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
2
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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3
510(k) SUMMARY K162529
| Company Name: Allengers Medical Systems Limited | |||
|---|---|---|---|
| Address: Bhankharpur, Mubarakpur | |||
| Road, Derabassi, Distt Mohali-140507 | |||
| India | |||
| 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.
4
| 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 |
5
| 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:
6
| Feature | DigiX FDX | Predicate
Siemens Ysio | Same or Similar
to predicate |
|--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) | K162529 | K081722 | |
| 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. | The Ysio (New RAD-
Family) systems are
the radiographic
systems used in
hospitals, clinics, and
medical practices.
Ysio enables
radiographic and
tomographic
exposures 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.
Exposures may be
taken with the patient
sitting, standing, or in
the prone position.
The Ysio system is not
meant for
mammography.
The Ysio uses an
integrated or portable
digital detector for
generating diagnostic
images by converting
x-rays into electronic
signals. Ysio is also
designed to be used
with conventional
film/screen or
Computed
Radiography (CR)
Cassettes. | Essentially the Same
Note:
There are no
differences between
the subject device and
the predicate with
respect to indication
and intended use. |
| Feature | DigiX FDX | Predicate
Siemens Ysio | Same or Similar
to predicate |
| | 2. Ceiling mounted x-ray tube suspension | | |
| Model | CSAAdv & CSAFDX | Ysio | |
| Longitudinal
travel | 300 cm | 346 cm | Similar with less travel,
provides full patient
coverage. Does not
affect safety or
effectiveness. |
| Transverse
travel | 200 cm | 220 cm | Similar with less travel,
provides full patient
coverage |
| Vertical travel | 150 cm | 190 cm | Similar with less travel,
provides full patient
coverage |
| 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 patient
coverage |
| Model | VBS M XL | BWS wi-D | |
| Vertical travel | 162 cm | 141 cm | Similar with more travel,
provides full patient
coverage |
| 4. Patient Table | | | |
| Model | FloatexXL | Bucky Table | |
| Type | 4-way float top | 4-way Float Top | Same |
| Longitudinal
travel | 95 cm, ±10 mm | N/A | Similar, provides patient
positioning. Does not
affect safety or
effectiveness. |
| Transverse
travel | 25 cm, ±10 mm | N/A | Similar, provides patient
positioning. Does not
affect safety or
effectiveness. |
| Table top locking | Electromagnetic | Electromagnetic | Same |
| Feature | DigiX FDX | Predicate
Siemens Ysio | Same or Similar
to predicate |
| Maximum patient
capacity | 200 kg (440 lbs) | 300 kg (660 lbs) | Similar with less
capacity. Does not
affect safety or
effectiveness. |
| Optional Model | Floatex+ | Bucky Table | N/A |
| Type | 6-way float top | 6-way float top | Same |
| Longitudinal
travel | 53.5 cm, ±10mm | N/A | N/A |
| Transverse
travel | 18 cm, ±10mm | N/A | N/A |
| Vertical travel | 26.5 cm, ±10mm | 29 cm | Similar with less travel.
Does not affect safety
or effectiveness. |
| Table top locking | Electromagnetic | Electromagnetic | Same |
| Maximum patient
capacity | 200 kg (440 lbs) | 300 kg (660 lbs) | Similar with less
capacity. Does not
affect safety or
effectiveness. |
| Optional Model | Floatex | N/A | N/A |
| Type | 4-way floating top | N/A | N/A |
| Longitudinal
travel | 53.5 cm, ±10mm | N/A | N/A |
| Transverse
travel | 20 cm, ±10mm | N/A | N/A |
| Table top locking | Electromagnetic | N/A | N/A |
| Maximum patient
capacity | 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 |
| Longitudinal
travel | 60 cm, ±10 mm | N/A | N/A |
| Transverse
travel | 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 patient
capacity | 200 kg (440 lbs) | N/A | N/A |
| Feature | DigiX FDX | Predicate
Siemens Ysio | Same or Similar
to predicate |
| Optional Model | MobiT 4C | N/A | N/A |
| Type | Mobile with float top | N/A | N/A |
| Longitudinal
travel | 60 cm, ±10 mm | N/A | N/A |
| Transverse
travel | 20 cm, ±10 mm | N/A | N/A |
| Table top locking | Electromagnetic | N/A | N/A |
| Maximum patient
capacity | 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 patient
capacity | 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 |
| APR
programming | Yes | Yes | Same |
| 6. X-ray Tube | | | |
| Tube Type | Varian G1092 | Siemens OPTITOP | |
| Focal Spot sizes | 0.6mm / 1.2mm | 0.6mm / 1.0mm | Similar
Provides essentially the
same imaging
resolution on both focal
spots |
| Heat Units | 1 MHU | 783 kHU | Similar
G1092 higher loading |
| Target Angle | 12° | 12° | Same |
| Target Diameter | 108 mm | 100 mm | Similar
G1092 higher loading |
| Feature | DigiX FDX | Predicate
Siemens Ysio | Same or Similar
to 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 the
Same.
Large focal spot
provides essentially the
same imaging results. |
| Heat Units | 600 KHU | 600 KHU | Same |
| Target Angle | 12° | 16° | Similar
Provides full coverage
at 40" SID |
| Target Diameter | 102 mm | 100 mm | Similar
Provides higher
instantaneous focal
spot 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 | Predicate
Siemens Ysio | Same or Similar
to predicate |
| | a-Si, wired (integrated) | a-Si, wired (integrated) | |
| Active area | 432 mm X 432 mm | 429 mm X 429 mm | Essentially the Same
imaging area |
| Pixel pitch | 100 μm | 143 μm | Similar, provides higher
resolution |
| Pixel matrix | 4318 X 4320 | 3001 X 3001 | Similar, provides higher
resolution |
| Input scintillator | Cesium Iodide | Cesium Iodide | Same |
| Limiting
resolution | 5 lp/mm | 3.57 lp/mm | Similar, provides higher
resolution |
| 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 Same
imaging area |
| Pixel pitch | 100 μm | 144 μm | Similar, provides higher
resolution |
| Pixel matrix | 3556 X 4320 | 2372 X 3000 | Similar, provides higher
resolution |
| Input scintillator | Cesium Iodide | Cesium Iodide | Same |
| Limiting
resolution | 5 lp/mm | 3.57 lp/mm | Similar, provides higher
resolution |
| 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 Same
imaging area |
| Pixel pitch | 139 μm | 143 μm | Similar, provides higher
resolution |
| Pixel matrix | 3072 X 3072 | 3001 X 3001 | Similar, provides higher
resolution |
| Input scintillator | Cesium Iodide | Cesium Iodide | Same |
| Limiting
resolution | 3.6 lp/mm | 3.57 lp/mm | Similar, provides higher
resolution |
| Optional Model | Varian PaxScan 4336R | Thales Pixium 3543 | Secondary Predicate |
| Feature | DigiX FDX | Predicate
Siemens Ysio | Same or Similar
to 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 Same
imaging area |
| Pixel pitch | 139 µm | 144 µm | Similar, provides higher
resolution |
| Pixel matrix | 2560 X 3072 | 2372 X 3000 | Similar, provides higher
resolution |
| Input scintillator | Cesium Iodide | Cesium Iodide | Same |
| Limiting
resolution | 3.6 lp/mm | 3.57 lp/mm | Similar, provides higher
resolution |
| Optional Model | Varian PaxScan
4336W | 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 higher
resolution |
| Pixel pitch | 139 µm | 144 µm | Similar, provides higher
resolution |
| Pixel matrix | 2560 X 3072 | 2372 X 3000 | Essentially the Same |
| Input scintillator | Cesium Iodide | Cesium Iodide | Similar, provides higher
resolution |
| Limiting
resolution | 3.6 lp/mm | 3.57 lp/mm | Similar, provides higher
resolution |
| 9. Viewing Monitors | | | |
| Monitor | 19 inch Medical
Monitor(1280 X 1024) | 19 inch Medical
Monitor(1280 X 1024) | Same |
| 10. Software Features | | | |
| Model | DROC | DelWorks DR System | Secondary Predicate |
| FDA Cleared | Yes, K130883 | Yes, K140825 | Same |
| Operating
System | Microsoft Windows 7 | Microsoft Windows 7 | Same |
| Network | Ethernet / Wifi | Ethernet / Wifi | Same |
| User | Mouse, Keyboard, | Mouse, Keyboard, | Same |
| Feature | DigiX FDX | Predicate
Siemens Ysio | Same or Similar
to predicate |
| interaction/input | Touch Monitor, | Touch Monitor, | |
| Multi-user | Available | Available | Same |
| Import/Export
images | Yes | Yes | Same |
| Acquisition
device | Computed
Radiography Digital
X-ray Detector | Computed
Radiography Digital
X-ray Detector | Same |
| Image
Interferences | Detector dependent | Detector dependent | Same |
| Image
Organization | Yes
Patient
ID/Name/Study
instance UID Patient
ID/Name/Study
instance UID | Yes
Patient
ID/Name/Study
instance UID Patient
ID/Name/Study
instance UID | Same |
| Image Search
available | Yes | Yes | Same |
| Image Storage | Yes | Yes | Same |
| Database
storage | Yes | Yes | Same |
| Database
Software | MS-Access | MS-Access | Same |
| Image Viewing | Yes | Yes | Same |
| Image
Measurement | Yes | Yes | Same |
| Image
Annotation | Yes | Yes | Same |
| Image
Operations | Yes | Yes | Same |
| Same Security | Yes(Priority by User) | Yes(Priority by User) | Same |
| DICOM 3.0
Compatibility | Yes | Yes | Same |
| Generator
Control | Yes | Yes | Same |
| Generator
Control Protocols | Generator dependent | Generator dependent | Same |
| Raw image Data
Processing | Yes | Yes | Same |
| Feature | DigiX FDX | Predicate
Siemens Ysio | Same or Similar
to predicate |
| Post image data
processing | Yes | Yes | Same |
| RIS code
manager | Yes | Yes | Same |
7
8
9
5-0-7
10
11
12
13
14
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.
15
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.