DigiX FDX

K162529 · Allengers Medical Systems Limited · KPR · Mar 3, 2017 · Radiology

Device Facts

• Record ID: K162529
• Device Name: DigiX FDX
• Applicant: Allengers Medical Systems Limited
• Product Code: KPR · Radiology
• Decision Date: Mar 3, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1680
• Device Class: Class 2
• Attributes: Pediatric

Intended 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.

Device Story

DigiX FDX is a stationary X-ray system for general radiographic imaging. System components include ceiling-mounted X-ray tube suspension, vertical Bucky stand, patient table (fixed or mobile), X-ray generator, X-ray tube, beam-limiting device, and solid-state image receptor (fixed or wireless). Device converts X-rays into electronic signals to generate diagnostic images. Operated by clinicians in hospitals, clinics, and medical practices. System supports patient positioning (sitting, standing, prone). Output is a digital image used by healthcare providers for diagnostic decision-making. System integrates with conventional film/screen or CR cassettes. No integration with other software/hardware devices permitted.

Clinical Evidence

Bench testing only. No clinical data provided. Verification and validation testing, image evaluation, and safety testing were performed. All system functions met design requirements and image performance criteria. Software/firmware testing confirmed DROC software and IntegraX firmware integration functioned as intended.

Technological Characteristics

Stationary X-ray system. Components: ceiling-mounted tube suspension, vertical Bucky stand, patient table, X-ray generator (65/80 kW), X-ray tube (Varian), beam-limiting device (Ralco), and solid-state detectors (a-Si TFT with Cesium Iodide scintillator). Connectivity: DICOM 3.0, Ethernet/Wi-Fi. Software: DROC (Windows 7). Safety standards: IEC 60601-1, IEC 60601-1-3, IEC 60601-2-54, EN 62304.

Indications for Use

Indicated for radiographic imaging of the whole body (skull, chest, abdomen, extremities) in pediatric, adult, and bariatric patients. Used for intravenous, small interventions (biopsy, punctures), and emergency/trauma applications. Contraindicated for mammography.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Siemens Ysio (K081722)

Reference Devices

• Varian PaxScan 4343R (K130318)
• Varian PaxScan 4336R (K130318)
• Perkin Elmer XRPAD 4343F (K142698)
• Varian PaxScan 4336W (K142049)
• Perkin Elmer XRPAD 4336 (K140551)
• e-COM Technology Ltd. DROC (K130883)
• DelWorks DR System (K140825)

Submission Summary (Full Text)

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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.

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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 [phone] or [phone] 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 [phone] or [phone] 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)

| <span> <span style="font-size:16px">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
|-----------------------------------------------------------------------------------------------------|
| <span> <span style="font-size:16px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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### 510(k) SUMMARY K162529

| | Company Name: Allengers Medical Systems Limited | | |
|-----------------------|-------------------------------------------------------------------------------------|--|--|
| | Address: Bhankharpur, Mubarakpur<br>Road, Derabassi, Distt Mohali-140507<br>India | | |
| Telephone No: | +91-01762-662626,663602<br>[phone] | | |
| 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<br>(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 | Predicate<br>Siemens Ysio | Same or Similar<br>to predicate |
|--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) | K162529 | K081722 | |
| Indications for<br>Use | The DigiX FDX<br>radiographic systems<br>are used in hospitals,<br>clinics and medical<br>practices. DigiX FDX<br>enables radiographic<br>exposure of the whole<br>body including: skull,<br>chest, abdomen, and<br>extremities and may<br>be used on pediatric,<br>adult and bariatric<br>patients. It can also be<br>used for intravenous,<br>small interventions<br>(like biopsy,<br>punctures, etc.) and<br>emergency (trauma<br>critical ill) applications.<br>Exposure may be<br>taken with the<br>Patient's sitting,<br>standing, or in the<br>prone position.<br>The DigiX FDX<br>System is not meant<br>for mammography.<br>The DigiX FDX uses<br>an integrated (fixed) or<br>portable<br>wired/wireless<br>detector for generating<br>diagnostic images by<br>converting X-Ray into<br>electronics signals.<br>DigiX FDX is also<br>designed to be used<br>with conventional<br>film/screen or<br>Computed<br>Radiography (CR)<br>Cassettes. | The Ysio (New RAD-<br>Family) systems are<br>the radiographic<br>systems used in<br>hospitals, clinics, and<br>medical practices.<br>Ysio enables<br>radiographic and<br>tomographic<br>exposures of the<br>whole body including:<br>skull, chest, abdomen,<br>and extremities and<br>may be used on<br>pediatric, adult and<br>bariatric patients. It<br>can also be used for<br>intravenous, small<br>interventions (like<br>biopsy, punctures,<br>etc.) and emergency<br>(trauma, critical ill)<br>applications.<br>Exposures may be<br>taken with the patient<br>sitting, standing, or in<br>the prone position.<br>The Ysio system is not<br>meant for<br>mammography.<br>The Ysio uses an<br>integrated or portable<br>digital detector for<br>generating diagnostic<br>images by converting<br>x-rays into electronic<br>signals. Ysio is also<br>designed to be used<br>with conventional<br>film/screen or<br>Computed<br>Radiography (CR)<br>Cassettes. | Essentially the Same<br>Note:<br>There are no<br>differences between<br>the subject device and<br>the predicate with<br>respect to indication<br>and intended use. |
| Feature | DigiX FDX | Predicate<br>Siemens Ysio | Same or Similar<br>to predicate |
| | 2. Ceiling mounted x-ray tube suspension | | |
| Model | CSAAdv & CSAFDX | Ysio | |
| Longitudinal<br>travel | 300 cm | 346 cm | Similar with less travel,<br>provides full patient<br>coverage. Does not<br>affect safety or<br>effectiveness. |
| Transverse<br>travel | 200 cm | 220 cm | Similar with less travel,<br>provides full patient<br>coverage |
| Vertical travel | 150 cm | 190 cm | Similar with less travel,<br>provides full patient<br>coverage |
| Tube rotation<br>(horiz.) | ±180° | ±180° | Same |
| Tube rotation<br>(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,<br>provides full patient<br>coverage |
| Model | VBS M XL | BWS wi-D | |
| Vertical travel | 162 cm | 141 cm | Similar with more travel,<br>provides full patient<br>coverage |
| 4. Patient Table | | | |
| Model | FloatexXL | Bucky Table | |
| Type | 4-way float top | 4-way Float Top | Same |
| Longitudinal<br>travel | 95 cm, ±10 mm | N/A | Similar, provides patient<br>positioning. Does not<br>affect safety or<br>effectiveness. |
| Transverse<br>travel | 25 cm, ±10 mm | N/A | Similar, provides patient<br>positioning. Does not<br>affect safety or<br>effectiveness. |
| Table top locking | Electromagnetic | Electromagnetic | Same |
| Feature | DigiX FDX | Predicate<br>Siemens Ysio | Same or Similar<br>to predicate |
| Maximum patient<br>capacity | 200 kg (440 lbs) | 300 kg (660 lbs) | Similar with less<br>capacity. Does not<br>affect safety or<br>effectiveness. |
| Optional Model | Floatex+ | Bucky Table | N/A |
| Type | 6-way float top | 6-way float top | Same |
| Longitudinal<br>travel | 53.5 cm, ±10mm | N/A | N/A |
| Transverse<br>travel | 18 cm, ±10mm | N/A | N/A |
| Vertical travel | 26.5 cm, ±10mm | 29 cm…