Digiscan FDX

K200218 · Allengers Medical Systems Limited · OWB · Jul 13, 2020 · Radiology

Device Facts

• Record ID: K200218
• Device Name: Digiscan FDX
• Applicant: Allengers Medical Systems Limited
• Product Code: OWB · Radiology
• Decision Date: Jul 13, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1650
• Device Class: Class 2

Intended Use

The Digiscan FDX Family, a Mobile C-Arm X-Ray System, is intended to provide Fluoroscopic images of the patient during diagnostic, surgical procedures. Clinical applications may include (but not limited to) orthopedic, Fertility studies (HSG), GI procedures like endoscopy , neurology, urology, critical care and emergency room procedures. Digiscan FDX C-Arm is indicated for visualization in real time and/or recording of surgical region of interest and anatomy, using X-Ray imaging technique.

Device Story

Digiscan FDX is a mobile C-arm X-ray system for intraoperative and diagnostic fluoroscopic imaging. It consists of a C-arm unit, X-ray generator, X-ray tube, solid-state flat panel detector (FPD), and a workstation with monitors. Operated by radiation experts (physicians/technicians) in clinical settings like ORs or ERs, the device captures real-time X-ray images of anatomical structures. The system transforms X-ray inputs into digital images via the Synergy FDX-CR imaging software, which manages image storage, display, and DICOM-compliant communication. Clinicians use these images for real-time guidance during surgical or diagnostic procedures, such as orthopedic or GI interventions. The device aids clinical decision-making by providing high-quality visualization of the surgical site, potentially improving procedural outcomes. It supports various movements (horizontal, orbital, vertical, wig-wag, rotation) for precise patient positioning.

Clinical Evidence

No clinical trials were conducted. Evidence consists of bench testing, including functional motion system testing, imaging performance evaluation, and safety compliance (IEC 60601-1, IEC 60601-2-54). Qualitative assessments by clinicians (urologists, orthopedists, gastroenterologists, neurologists) confirmed that acquired images (cardiac, neurology, fluoroscopic loops, LIH, digital spot) were of adequate quality for the intended use.

Technological Characteristics

Mobile C-arm X-ray system. Components: high-frequency X-ray generator, rotating/stationary anode X-ray tubes, solid-state flat panel detectors (amorphous silicon or CMOS), and workstation. Connectivity: DICOM 3.0, Ethernet/WLAN. Standards: IEC 60601-1 (safety), IEC 60601-2-54 (X-ray equipment), IEC 62304 (software). Software: Synergy FDX-CR. Sterilization: N/A (not sterile).

Indications for Use

Indicated for real-time visualization and recording of surgical regions of interest and anatomy using X-ray imaging in diagnostic and surgical procedures (orthopedic, fertility/HSG, GI/endoscopy, neurology, urology, critical care, ER). Contraindicated for pregnancy. Not recommended for mammography.

Regulatory Classification

Identification

An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. 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). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic 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. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device 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

• Ziehm Vision RFD (K132904)

Reference Devices

• OEC Elite (K172550)
• Cios Fusion (K153244)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains 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, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Allengers Medical Systems Limited % Sanjeev Marjara Director Technical FDA Hall, Unit II, Bhankarpur, Mubarakpur Road, Derabassi, Distt Mohali, Punjab 140507 INDIA

Re: K200218

Trade/Device Name: Digiscan FDX Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: Class II Product Code: OWB, JAA, OXO

Dear Sanjeev Marjara:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated July 3, 2020. Specifically, FDA is updating this SE Letter as an administrative correction.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Laurel Burk, OHT7: Office of In Vitro Diagnostics and Radiological Health, [phone], laurel.burk(@fda.hhs.gov.

Sincerely,

| Laurel M. | Digitally signed by<br>Laurel M. Burk -S | |
|-----------|------------------------------------------|-----|
| Burk -S | Date: 2020.08.07<br>09:44:10 -04'00' | For |

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

August 7, 2020

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Image /page/1/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "U.S. Food & Drug Administration" in blue letters. The logos are placed side by side.

Allengers Medical Systems Limited % Sanjeev Marjara Director Technical FDA Hall, Unit II, Bhankarpur, Mubarakpur Road, Derabassi, Distt Mohali, Punjab 140507 INDIA

#### Re: K200218

Trade/Device Name: Digiscan FDX Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: Class II Product Code: OWB, JAA, OXO Dated: June 9, 2020 Received: June 15, 2020

#### Dear Sanjeev Marjara:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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

July 15, 2020

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@tda.hhs.gov) or phone [phone] or 301-796-7100).

Sincerely,

Michael D. O'Hara
For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K200218

Device Name

Digiscan FDX

#### Indications for Use (Describe)

The Digiscan FDX Family, a Mobile C-Arm X-Ray System, is intended to provide Fluoroscopic images of the patient during diagnostic, surgical procedures.

Clinical applications may include (but not limited to) orthopedic, Fertility studies (HSG), Gl procedures like endoscopy , neurology, urology, critical care and emergency room procedures.

Digiscan FDX C-Arm is indicated for visualization in real time and/or recording of surgical region of interest and anatomy, using X-Ray imaging technique.

Exclusion: Digiscan FDX Family is not recommended for Mammography.

Contraindications: Exposure of X-Ray should be avoided during pregnancy.

| 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

(K200218)

This summary of 510(k) is being submitted in accordance with requirements of SMDA1990 and 21 CFR Part 807.92.

# 1. Contact Person and Address

| Company Name: | Allengers Medical Systems Limited |
|------------------|-------------------------------------------------------------------------------------------|
| Company Address: | FDA Hall, Unit II, Bhankharpur, Mubarakpur<br>Road, Derabassi, Distt Mohali-140507, India |
| Telephone No: | [phone]<br>[phone]<br>[e-mail] |
| Contact Person: | Sanjeev K. Marjara |
| Date Prepared: | 11 July 2020 |

#### 2. Proposed Device:

| Device (trade) name: | Digiscan FDX |
|-----------------------|------------------------------------------------|
| Model Number: | Digiscan FDX-V, Digiscan FDX-R, Digiscan FDX-S |
| Common Name: | Flat Panel Based High Frequency C-Arm Machine |
| Classification Name: | Image-Intensified Fluoroscopic X-Ray System |
| Classification Panel: | Radiology |
| Regulation Number: | 21 CFR 892.1650 |
| Device Class: | Class II |
| Product Code: | OWB, JAA, OXO |

## 3. Predicate Device:

| Device (trade) name: | Ziehim Vision RFD |
|-----------------------|---------------------------------------------|
| 510(K) Number : | K132904 |
| Clearance Date : | December 05, 2013 |
| Classification Name: | Image-Intensified Fluoroscopic X-Ray System |
| Classification Panel: | Radiology |
| Regulation Number : | 21 CFR 892.1650 |
| Device Class : | Class II |
| Product Code: | OWB, JAA, OXO |

## 4. Reference devices:

#### Reference Device

| Device (trade) name: | OEC Elite |
|-----------------------|---------------------------------------------|
| 510(K) Number: | K172550 |
| Clearance Date: | November 16, 2017 |
| Classification Name: | Image-Intensified Fluoroscopic X-Ray System |
| Classification Panel: | Radiology |
| Regulation Number: | 21 CFR 892.1650 |
| Device Class: | Class II |
| Product Code: | OWB, JAA, OXO |

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### Reference Device

| Device (trade) name: | Cios Fusion |
|-----------------------|---------------------------------------------|
| 510(K) Number: | K153244 |
| Clearance Date: | March 7, 2016 |
| Classification Name: | Image-Intensified Fluoroscopic X-Ray System |
| Classification Panel: | Radiology |
| Regulation Number: | 21 CFR 892.1650 |
| Device Class: | Class II |
| Product Code: | OWB, JAA, OXO |

Allengers Medical Systems Ltd. Supplies Solid State X-Ray Image Detectors that have been previously cleared by FDA or tested and evaluated per quidance for submission of 510(K) for solid state X-Ray imaging devices. Table 1 provides the list of solid state detectors used with device.

| Solid State Detectors | 510(K) Numbers |
|------------------------------------------|----------------|
| Varex Imaging corporation – Paxscan 2020 | K100102 |
| Varex Imaging corporation - Paxscan 3030 | K113548 |
| MX Imaging – CFP 2222 | K171755 |
| MX Imaging – CFP 3131 | K171755 |
| Thales Group – Pixium Surgical 2121S-A | K183040 |
| Thales Group – Pixium 2121S-AU | -- |
| Thales Group – Pixium Surgical 3030S-A | K172822 |
| Thales Group – Pixium 3030S-AU | -- |
| IRAY Technology – Mercu 0909F | -- |

Table 1 List of Solid State X-Ray Image Detectors

## 5. Device description:

The Digiscan FDX Family (Digiscan FDX-V, Digiscan FDX-R and Digiscan FDX-S) are mobile X-Ray C-Arm fluoroscopic device used by radiation experts. Digiscan FDX family is a digital fluoroscopic imaging system with Solid State X-Ray Image Detetors (FPD) used in diagnostic. The device is designed in such a way that it can moved around and can be positioned for the required be anatomical/clinical/procedural position.

Digiscan FDX family composed of C-Arm, X-Ray generating equipment (X-Ray controller, high voltage generator, X-Ray tube), FPD, and workstation (Console computer and Monitor(s)). C-Arm unit with generator is capable of movements which are essential for patient positioning, like horizontal travel, orbital movement, vertical movement, wig-wag movement and C rotation. The X-Ray generator, X-Ray control system and collimator controls are housed in the C-Arm unit.

Synergy FDX-CR imaging software is a Digital Imaging System (DIS) designed for C-arm Fluoroscopic Mobile X-Ray System. Synergy FDX-CR imaging software provides useful functions to manage X-Ray images obtained from Digiscan FDX family FPD Fluoroscopic Mobile X-Ray System.

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The following in Table 2 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 |
|--------------------------------------|---------------------------------|----------------------------|
| X-Ray Generator | Allengers Digiscan FDX-V | XGEN-15 |
| X-Ray Generator | Allengers Digiscan FDX-R | XGEN-6 |
| X-Ray Generator | Allengers Digiscan FDX-S | XGEN-3.5 |
| X-Ray Tube | Varex Imaging Digiscan FDX-V | A-145 |
| | Varex Imaging Digiscan FDX-R | RAD 99 |
| | Varex Imaging Digiscan FDX-R | RAD 99B |
| X-Ray Tube | Hangzhou Wandong Digiscan FDX-V | XD-56 5/17 |
| | Hangzhou Wandong Digiscan FDX-R | |
| X-Ray Tube | Hangzhou Kailong Digiscan FDX-S | KL25-0.6/1.5-125 |
| X-Ray Tube | C.E.I Digiscan FDX-S | OX/110-0514 |
| Solid State X-Ray<br>Image Detectors | Varex Imaging Digiscan FDX-V | Paxscan 2020 |
| | Varex Imaging Digiscan FDX-R | Paxscan 3030 |
| | Varex Imaging Digiscan FDX-S | |
| Solid State X-Ray<br>Image Detectors | IRAY Technology Digiscan FDX-V | |
| | IRAY Technology Digiscan FDX-R | Mercu 0909F |
| | IRAY Technology Digiscan FDX-S | |
| Solid State X-Ray<br>Image Detectors | Thales Group Digiscan FDX-V | Pixium 2121S-AU |
| | Thales Group Digiscan FDX-R | Pixium Surgical<br>2121S-A |
| | Thales Group Digiscan FDX-S | Pixium Surgical<br>3030S-A |
| Solid State X-Ray<br>Image Detectors | MX Imaging Digiscan FDX-V | |
| | MX Imaging Digiscan FDX-R | CFP 2222 |
| | MX Imaging Digiscan FDX-S | CFP 3131 |

Table 2 Combination Details

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#### 6. Indications for Use:

The Digiscan FDX Family, a Mobile C-Arm X-Ray System, is intended to provide Fluoroscopic images of the patient during diagnostic, surgical procedures.

Clinical applications may include (but not limited to) orthopedic, Fertility studies (HSG), GI procedures like endoscopy, neurology, critical care and emergency room procedures.

Digiscan FDX C-Arm is indicated for visualization in real time and/or recording of surgical region of interest and anatomy, using X-Ray imaging technique.

Exclusion: Digiscan FDX Family is not recommended for Mammography.

Contraindications: Exposure of X-Ray should be avoided during pregnancy.

#### 7. Technological Characteristics Comparison to Predicate & Reference Devices:

The Digiscan FDX family having set of components similar to the Ziehm Vision RFD. OEC Elite and Cios fusion System as compared in Table 3 found below in this Section. This table below shows that the systems are either similar, or the same, as the predicate & reference devices.

#### 8. Software Feature

The software feature set and functions is essentially the same as the predicate & reference devices, with the system complying with DICOM 3.0 specifications .Refer to section 11 Image processing and storage of the following table for a list of top level functions

#### 9. Substantial Equivalence:

The Digiscan FDX Mobile C-Arm X-Ray Machine is substantially equivalent to the commercially available Ziehm Vision RFD (K132904), OEC Elite (K172550) and Cios Fusion (K153244). Functional and specification differences are identifying in the following table.

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Table 3: Functional and specification differe

| Feature | Digiscan FDX<br>(Subject Device) | Ziehm Vision RFD<br>(Predicate Device) | OEC Elite<br>(Reference Device) | Cios Fusion<br>(Reference Device) | Discussion of<br>Difference |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1. 510(k) | K200218 | K132904 | K172550 | K153244 | |
| 2. Product Code | OXO, OWB, and JAA | OXO, OWB and JAA | OXO, OWB and JAA | OXO, OWB and JAA | Same |
| 3. Product Classification | 21 CFR 892.1650 | 21 CFR 892.1650 | 21 CFR 892.1650 | 21 CFR 892.1650 | Same |
| 4. Indication for Use | The Digiscan FDX a Mobile<br>C-Arm X-Ray System, is<br>intended to provide<br>Fluoroscopic images of the<br>patient during diagnostic,<br>surgical procedures. | The ZIEHM VISION RFD is<br>intended for use in providing<br>medical imaging, using pulsed<br>and continuous fluoroscopic<br>digital imaging, as well as digital<br>subtraction and cine image<br>capture during diagnostic<br>interventional and surgical<br>procedures where<br>intraoperative imaging and<br>visualization of complex<br>anatomical structures of both<br>lower and higher contrast<br>density are required. Such<br>procedures may include but are<br>not limited to those of | The OEC Elite mobile<br>fluoroscopy system is<br>designed to provide<br>fluoroscopic and<br>digital spot images of<br>adult and<br>pediatric patient<br>populations during<br>diagnostic,<br>interventional, and<br>surgical procedures.<br>Examples of a clinical<br>application<br>may include:<br>orthopedic,<br>gastrointestinal,<br>endoscopic, urologic,<br>neurologic, vascular,<br>cardiac, critical care,<br>and emergency<br>procedures. | The Cios Fusion is a<br>mobile X-Ray system<br>designed to provide X-<br>Ray imaging of the<br>anatomical structures of<br>patient<br>During clinical<br>applications. Clinical<br>applications may<br>include but are not<br>limited to: interventional<br>fluoroscopic,<br>gastrointestinal,<br>endoscopic, urologic,<br>pain management,<br>orthopedic, neurologic,<br>vascular, cardiac,<br>critical care and<br>emergency<br>room procedures. The<br>patient population may<br>include pediatric | Essentially the<br>same<br>Note: There are no<br>differences<br>between<br>the subject device<br>and the predicate &<br>reference devices<br>with respect to<br>indication and<br>intended use. |
| Indications for<br>Use | Clinical applications may<br>include (but are not limited<br>to ) orthopaedic, Fertility<br>studies (HSG), GI<br>procedures like endoscopy<br>, neurology, urology,<br>critical care and emergency<br>room procedures.<br><br>Digiscan FDX C-Arm is<br>indicated for visualization in<br>real time and/or recording<br>of surgical region of interest<br>and anatomy, using X-Ray<br>imaging technique. | interventional cardiology, heart<br>surgery, hybrid procedures,<br>interventional radiology,<br>interventional angiography,<br>electrophysiology, pediatrics,<br>endloscopic, | | | |

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| Exclusion: Digiscan FDX<br>is not recommended for<br>Mammography. | Contraindications:<br>Exposure of X-Ray should<br>be avoided during<br>pregnancy. | patients. |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|-----------|
| urological, gastroenterology,<br>orthopedic, maxillofacial<br>surgery, neurology,<br>neurosurgery, critical care,<br>emergency roomprocedures,<br>and those procedures<br>visualizing structures of the<br>cervical, thoracic, and lumber<br>regions of the spine and joint<br>fractures of the upper and lower<br>extremities, and where digital<br>image data is required for<br>computer aided surgery<br>procedures, and whenever the<br>clinician benefits from the high<br>degree of geometric imaging<br>accuracy, and where such<br>fluoroscopic, cine and DSA<br>imaging is required in and<br>around high magnetic fields.<br>The visualization of such<br>anatomical structures assists<br>the clinician in the clinical<br>outcome. At the discretion of a<br>physician, the device may be<br>used or other imaging<br>applications.<br>This device does not support<br>direct radiographic film<br>exposures and is not intended<br>for use in performing<br>mammography. The system is<br>not intended for use near MRI<br>systems. | | |

Section 5-0

5-0-6

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| 5. X-Ray Generator | | | | | | | |
|-------------------------------------|-------------------------------------------|----------------------------------------------------|-------------------------------------------|----------------------------------|-------------------------------------------|----------------------------------------------------------------|--------------------|
| Type | Monoblock and High<br>Frequency Generator | Kilowatt Rating | Monoblock and High Frequency<br>Generator | High Frequency split<br>block | Monoblock and High<br>Frequency Generator | Same | |
| | | Digiscan FDX-V<br>Digiscan FDX-R<br>Digiscan FDX-S | 15KW<br>6KW<br>3.5KW | 20 KW Standard<br>7.5KW Optional | 15KW | 2.3 KW | Similar<br>(SE #1) |
| KV Minimum | 40 KV | | 40 KV | 40 KV | 40 KV | Same | |
| KV Maximum | 120KV | | 120 KV | 120KV | 110 KV | Same as Predicate<br>Device &<br>Reference Device<br>OEC Elite | |
| Dose Control<br>System | Yes | | Yes | Yes | Yes | Same | |
| Dose Area<br>Product | Yes | | Yes | Yes | Yes | Same | |
| 6. X-Ray Tube | | | | | | | |
| Model | A-145 | | -- | -- | -- | -- | |
| Tube Type | Rotating Anode | | Rotating Anode | Rotating Anode | NA | Same | |
| Cooling<br>HU/min | 70000 HU/ min | | 85000 HU/min | 85000 HU/min | NA | Similar (SE #2) | |
| Anode Heat<br>Capacity | 300 KHU | | 365 KHU | 300 KHU | NA | Same as<br>Reference Device<br>OEC Elite. | |
| Focal Spot<br>Size, mm | Dual Focus 0.3/0.6 | | Dual Focus 0.3/0.6 | Dual Focus 0.3/0.6 | NA | Same | |
| Maximum<br>Tube Power<br>Rating, KW | 25 KW | | 25 KW | 15KW | NA | Same as Predicate<br>Device | |

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| Optional | | | | | | | Optional | | | | | | |
|-------------------------------|--------------------|-------------------------------------|-------------------------------------|--------------------|--------------------|-----------------|----------|--|--|--|--|--|--|
| Model | RAD 99B | -- | -- | RAD 99 | -- | -- | | | | | | | |
| Tube Type | Rotating Anode | Rotating Anode | Rotating Anode | Rotating Anode | Rotating Anode | Rotating Anode | | | | | | | |
| Cooling HU/min | 85280 HU/min | 85000 HU/min | NA | 70000 HU/min | 85000 HU/min | NA | | | | | | | |
| Anode Heat Capacity | 300 KHU | 365 KHU | NA | 300 KHU | 300 KHU | NA | | | | | | | |
| Focal Spot Size, mm | Dual Focus 0.3/0.6 | Dual Focus 0.3/0.6 | NA | Dual Focus 0.3/0.6 | Dual Focus 0.3/0.6 | NA | | | | | | | |
| Maximum Tube Power Rating, KW | 22.5 KW | 25 KW | NA | 22.5 KW | 25 KW | NA | | | | | | | |
| | | Same | Similar (SE #2) | | Same | Similar (SE #2) | | | | | | | |
| | | Same as Reference Device OEC Elite. | Same as Reference Device OEC Elite. | | | | | | | | | | |
| | | Same | Same | | | | | | | | | | |
| | | Similar (SE #4) | Similar (SE #4) | | | | | | | | | | |

Allengers Medical Systems Limited Diigiscan FDX 510(k)

Section 5-0

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| | Allengers Medical Systems Limited | | | | |
|-------------------------------|-----------------------------------|--------------------|--------------------|----|--------|
| Model | XD56-5/17/130 | -- | -- | -- | |
| Tube Type | Rotating Anode | Rotating Anode | Rotating Anode | NA | S |
| Cooling HU/min | 25000 HU/ min | 85000 HU/min | 85000 HU/min | NA | S |
| Anode Heat Capacity | 300 KHU | 365 KHU | 300 KHU | NA | R<br>C |
| Focal Spot Size, mm | Dual Focus 0.3/0.6 | Dual Focus 0.3/0.6 | Dual Focus 0.3/0.6 | NA | S |
| Maximum Tube Power rating, KW | 17 KW | 25 KW | 15KW | NA | S |
| Optional | | | | | |

| nited<br>im<br>Li<br>l |
|------------------------|
| Systems |
| Medical |
| llengers |

| | or in the | | | | |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------|-------------------|-----------------|---------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ube Type | otating Anoc | Anode<br>Rotating | otating Anod | র্বাম | Same |
| Cooling HU/min | 5000 HU/ mir | HU/mir<br>35000 | 5000 HU/mi | NA | (SE #2<br>Similar |
| node Hea Capacity | 300 KHL | 365 KHU | 300 KHL | রাম | Same as Reference Devic OEC Elite. |
| Focal Spor Size, mm | ual Focus 0.3/0 | Dual Focus 0.3/0 | ual Focus 0.3/0 | NA | Same |
| ្រព្រែកច្រើន ព្រះពុទ្ធសាសនា ស្រី នារា ស្រុក ស្រុក ស្រុក ស្រុក ស្រុក ស្រុក ស្រុក ស្រុក ស្រុក ស្រុក ស្រុក ស្រុក ស្រុក ស្រុក ស្រុក ស្រុក ស្រុក ស្រុក ស្រុក | 17 KW | 25 KW | 5KW | রাম | (SE #4<br>Similar |
| | | | | | |
| Model | .25-0.6/1.5-12 | - | - | - | |
| ube Type | ationary Anod | র্বাম | র | ationary Anod | Same |
| Cooling HU/min | 3800 HU/ mi | NA | NA | 7300 HU/ mir | (SE #2<br>Similar |
| ട് വലിവാഹം പ്രാറ്റലും പുറത്തുക വാഴ്ച്ചുകളുടെ വാറ്റ് വാഴ്ച്ചു ശ്വീകരുമുള്ള ശ്വീകരുമുള്ള ശ്വീകരുമുള്ള ശ്വീകരുമുള്ള പ്ര | 42 KHU | NA | র্বাম | 61.1 KHL | SE #3<br>Similar |
| | ual Focus 0.6/ | NA | NA | 0.6 | (SE #5<br>Similar |
| מורים חיצוניים | 4 KW | রাম | রাম | 2.3 KW | (SE #4<br>Similar |
| | | | | | |
| Model | X/110-05 | - | -- | -- | |
| ube Type | ationary And | NA | NA | ationary Ano | lame as Reference devic Cios Fusion. _________________________________________________________________________________________________________________________________________ |
| | | | | | |

Section 5-0

5-0-9

{13}------------------------------------------------

| | | | | | | | Allengers Medical Systems Limited | | | | | | |
|-------------------------------------|--------------------------|--------------------------|----------------------------------------------|---------------|-----------------------------------------------------------------|--------------------------------------|-----------------------------------|---------------------------------------------------|----------------------------------------------|-----------------------------------------------|-----------------------------------|----------------------------|---------------------------------------------------------------|
| Cooling<br>HU/min | 46200 HU/ min | NA | NA | 37300 HU/ min | Similar (SE #2) | | | Max mA Range | | | | | |
| Anode Heat<br>Capacity | 42 KHU | NA | NA | 61.1 KHU | Similar (SE #3) | | Digiscan FDX-V | 0.2 mA-15 mA (Normal Mode)<br>0.2 mA -30 mA (HLF) | | | | | |
| Focal Spot<br>Size, mm | Dual Focus 0.5/1.4 | NA | NA | 0.6 | Similar (SE #5) | | Digiscan FDX-R | 0.2 mA-15 mA (Normal Mode)<br>0.2 mA -30 mA (HLF) | | 0.2- 10 mA (Normal mode)<br>0.2 – 20 mA (HLF) | 3 mA to 25 mA | Similar (SE #6) | |
| Maximum<br>Tube Power<br>Rating, KW | 4.5 KW | NA | NA | 2.3 KW | Similar (SE #4) | | Digiscan FDX-S | 0.2 mA-10 mA (Normal Mode)<br>0.2 mA -20 mA (HLF) | | | | | |
| 7. Radiographic Mode | | | | | | | Pulses per second (pps) (max) | | Upto 15 (1536*1536) ,<br>upto 30 (1024*1024) | 1 to 25 | upto 30 | upto 30 | Similar (SE #7) |
| KV Range | 40-120 KV | 40-120 KV | 40-120 KV | 40-110 KV | Same as Predicate<br>Device &<br>Reference Device<br>OEC Elite. | Cine (fps) (max) | | Upto 15 (1536*1536) ,<br>upto 30 (1024*1024) | 1-25 frames/s | upto 30 frames/s | upto 30 frame/s | Similar (SE #8) | |
| mA Range | Digiscan FDX-V<br>150 mA | Digiscan FDX-R<br>120 mA | 7.5 KW - 1.5 - 75 mA<br>20 KW - 1.5 - 200 mA | Upto 75 mA | Similar (SE #6) | 9. Solid State X-Ray Image Detectors | | | | | | | |
| | Digiscan FDX-S<br>80 mA | | | Upto 25 mA | | Make | | | Varex's, Paxscan 3030 | -- | -- | | |
| 8. Fluoroscopic Mode | | | | | | | Type | | | Amorphous Silicon | CMOS | Amorphous Silicon | Same as Predicate Device &<br>Reference Device<br>Cios Fusion |
| KV Range | 40-120 kV | 40-120 KV | 40-120 KV | 40-110 KV | Same as Predicate<br>Device &<br>Reference Device<br>OEC Elite. | Active Area | | | 298mm (h) x 298mm (v) (11.7 x 11.7 in) | -- | 305mm (h) x 305mm (v) (12 x12 in) | Same as Predicate Device | |
| Pulse<br>fluoroscopic | Yes | Yes | Yes | Yes | Same | Limiting resolution (Max) | | | 2.58 lp/mm | -- | 3.5 lp/mm | Same as Predicate Device | |
| ABS Control | Yes | Yes | Yes | Yes | Same | Pixel Matrix | | | 1,536 (h) x 1,536 (v) | 1548 (h) x 1524 (v) | 1536 (h) x 1,536 (v) | Same as Predicate Device & | |
| Snapshot<br>Mode | Yes | Yes | Yes | Yes | Same | | | | | | | | |

Allengers Medical Systems Limited Diigiscan FDX 510(k)

Section 5-0

{14}------------------------------------------------

Allengers Medical Systems Limited Diigiscan FDX 510(k)

Section 5-0

{15}------------------------------------------------

| DQE | 80% at 0lp/mm | 80% at 0lp/mm | 72% | 55% at 1lp/mm | Reference Device<br>Cios Fusion |
|---------------------------------------------|------------------------------------|---------------------------------------|------------------------------|--------------------------|------------------------------------------------------------------|
| Modulation<br>Transfer<br>Function<br>(MTF) | 55% at 1lp/mm | 55% at 1lp/mm | -- | 55% at 1lp/mm | Same as Predicate<br>Device &<br>Reference Device<br>Cios Fusion |
| A/D<br>Conversion | 16 bit | 16 bit | 16 bit | 16 bit | Same |
| Pixel Pitch | 194µm | 194µm | 198.0 µm | 194µm | Same as Predicate<br>Device &<br>Reference Device<br>Cios Fusion |
| <i>Optional</i> | | | | | |
| Make | Varex's, Paxscan 2020 | Varex's, Paxscan 2020 | -- | -- | -- |
| Type | Amorphous Silicon | Amorphous Silicon | CMOS | Amorphous Silicon | Same as Predicate<br>Device &<br>Reference Device<br>Cios Fusion |
| Active Area | 199mm (h) x 199mm (v) | 199mm (h) x 199mm (v) | -- | 203mm (h) x 203mm<br>(v) | Same as Predicate<br>Device |
| Limiting<br>resolution<br>(Max) | 2.58 lp/mm | 2.58 lp/mm | 3.5 lp/mm | 3.1lp/mm | Same as Predicate<br>Device |
| Pixel Matrix | 1,024 (h) x 1,024 (v) | 1,024 (h) x 1,024 (v) | 1536 (h) x 1496 (v) | 1,024 (h) x 1,024 (v) | Same as Predicate<br>Device &<br>Reference Device<br>Cios Fusion |
| DQE | 80% at 0lp/mm | 80% at 1lp/mm | 72% | 55% at 1lp/mm | Same as Predicate<br>Device |
| Modulation<br>Transfer<br>Function<br>(MTF) | 55% at 1lp/mm | 55% at 1lp/mm | -- | 55% at 1lp/mm | Same as Predicate<br>Device &<br>Reference Device<br>Cios Fusion |
| VD<br>Conversion | 16 bit | 16 bit | 16 bit | 16 bit | Same |
| Pixel Pitch | 194μm | 194µm | 135.3 µm | 194µm | Same as Predicate<br>Device &<br>Reference Device<br>Cios Fusion |
| <i>Optional</i> | | | | | |
| Make | IRAY 's, Mercu 0909F | Varex, Paxscan 3030 | -- | Varex, Paxscan 3030 | -- |
| Type | Amorphous Silicon | Amorphous Silicon | NA | Amorphous Silicon | NA |
| Active Area | 228.6mm (h)x228.6mm (v) | 199mm (h) x 199mm (v) | NA | 199mm (h) x 199mm (v) | NA |
| Pixel Matrix | 1,024 (h) x 1,024 (v) | 1,024 (h) x 1,024 (v) | NA | 1,024 (h) x 1,024 (v) | NA |
| DQE | 77% at 0lp/mm | 80% at 1lp/mm | NA | 80% at 1lp/mm | NA |
| Modulation<br>Transfer<br>Function<br>(MTF) | 64% at 1lp/mm | 55% at 1lp/mm | NA | 55% at 1lp/mm | Similar (SE #9) |
| VD<br>Conversion | 16 bit | 16 bit | NA | 16 bit | Same |
| Pixel Pitch | 205µm | 194μm | NA | 194µm | Similar (SE #9) |
| <i>Optional</i> | | | | | |
| Make | Thales, Pixium 2121S-AU | Varex's, Paxscan 2020 | -- | Varex's, Paxscan 2020 | -- |
| Type | Amorphous Silicon | Amorphous Silicon | NA | Amorphous Silicon | Same |
| Active Area | 205mm (h) x 205mm (v) | 199mm (h) x 199mm (v) | NA | 199mm (h) x 199mm (v) | Similar (SE #9) |
| | Allengers Medical Systems Limited | | | | |
| Pixel Matrix | 1,024 (h) x 1,024 (v) | 1,024 (h) x 1,024 (v) | NA | NA | Same |
| DQE | 78% at 0lp/mm | 80% at 0lp/mm | NA | NA | Similar (SE #9) |
| Modulation<br>Transfer<br>Function<br>(MTF) | 53% at 1lp/mm | 55% at 1lp/mm | NA | NA | Similar (SE #9) |
| VD<br>Conversion | 16 bit | 16 bit | NA | NA | Same |
| Pixel Pitch | 200 μm | 194 μm | NA | NA | Similar (SE #9) |
| <i>Optional</i> | | | | | |
| Make | Thales, Pixium Surgical<br>2121S-A | Varex's, Paxscan 2020 | -- | -- | -- |
| Type | Amorphous Silicon | Amorphous Silicon | NA | NA | Same |
| Active Area | 207mm (h) x 207mm (v) | 199mm (h) x 199mm (v) | NA | NA | Similar (SE #9) |
| Pixel Matrix | 1,344 (h) x 1,344 (v) | 1,344 (h) x 1,024 (v) | NA | NA | Similar (SE #9) |
| DQE | 76% at 0lp/mm | 65% at 1lp/mm | NA | NA | Similar (SE #9) |
| Modulation<br>Transfer<br>Function<br>(MTF) | 59% at 1lp/mm | 55% at 1lp/mm | NA | NA | Similar (SE #9) |
| VD<br>Conversion | 16 bit | 16 bit | NA | NA | Same |
| Pixel Pitch | 154 μm | 194μm | NA | NA | Similar (SE #9) |
| <i>Optional</i> | | | | | |
| Make | MX CFP 2222 | Varex, Paxscan 3030 | -- | -- | -- |
| Type | CMOS | Amorphous Silicon | CMOS | NA | Same as<br>Reference Device<br>OEC Elite |
| | Allengers Medical Systems Limited | | | | |
| Active Area | 217mm (h) x 217mm (v) | 199mm (h) x 199mm (v) | NA | | Similar (SE #9) |
| Pixel Matrix | 2170 (h) x 2170 (v) | 1,024 (h) x 1,024 (v) | 1536 (h) x 1496 (v) | NA | Similar (SE #9) |
| DQE | 75% at 0lp/mm | 80% at 1lp/mm | 72% | NA | Similar (SE #9) |
| Modulation<br>Transfer<br>Function<br>(MTF) | 70% at 1lp/mm | 55% at 1lp/mm | Information not<br>available | NA | Similar (SE #9) |
| A/D<br>Conversion | 16 bit | 16 bit | 16 bit | NA | Same |
| Pixel Pitch | 100 μm | 194 μm | 135.3 μm | NA | Similar (SE #9) |
| <i>Optional</i> | | | | | |
| Make | MX CFP 3131 | Varex, Paxscan 3030 | -- | -- | -- |
| Type | CMOS | Amorphous Silicon | CMOS | NA | Same as<br>Reference Device<br>OEC Elite. |
| Active Area | 309.4mm (h) x 307.2mm (v) | 199mm (h) x 199mm (v) | | NA | Similar (SE #9) |
| Pixel Matrix | 3094 (h) x 3072 (v) | 1,024 (h) x 1,024 (v) | 1536 (h) x 1496 (v) | NA | Similar (SE #9) |
| DQE | 75% at 0lp/mm | 80% at 1lp/mm | 72% | NA | Similar (SE #9) |
| Modulation<br>Transfer<br>Function<br>(MTF) | 70% at 1lp/mm | 55% at 1lp/mm | Information not<br>available | NA | Similar (SE #9) |
| A/D<br>Conversion | 14 bit | 16 bit | 16 bit | NA | Similar (SE #9) |
| Pixel Pitch | 100 μm | 194μm | 135.3 µm | NA | Similar (SE #9) |
| <i>Optional</i> | | | | | |
| Make | Thales, Pixium Surgical<br>3030S-A | Varex Paxscan 3030 | -- | == | -- |
| | Allengers Medical Systems Limited | | | | |
| Type | Amorphous Silicon | Amorphous Silicon | NA | NA | Same |
| Active Area | 301mm (h) x301mm (v) | 298mm (h) x 298mm (v) | NA | NA | Similar (SE #9) |
| Pixel Matrix | 1,956 (h) x 1,956 (v) | 1,536 (h) x 1,536 (v) | NA | NA | Similar (SE #9) |
| DQE | 75% at 0lp/mm | 80% at 0lp/mm | NA | NA | Similar (SE #9) |
| Modulation Transfer Function (MTF) | 59% @ 1lp/mm |…