Digital C-ARM with 3D
Device Facts
| Record ID | K253296 |
|---|---|
| Device Name | Digital C-ARM with 3D |
| Applicant | Allengers Medical Systems Limited |
| Product Code | OXO · Radiology |
| Decision Date | Jun 5, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1650 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Indications for Use
Digiscan V30 3D is X-Ray based fluoroscopy equipment. It is intended for use in visualizing complex anatomical structures and procedures such as 3D Reconstruction, endoscopy Studies (ERCP), urology, Gastro, orthopedic, neurology, Fertility studies (HSG), cholangiography, vascular angiography with and without subtraction, critical care and emergency room procedures. This equipment produces real time images of anatomy using x-rays.
Device Story
Mobile C-arm fluoroscopic X-ray system; utilizes X-ray generator, tube, and solid-state flat panel detector (FPD) to capture real-time 2D and 3D images. Operated by radiation experts/physicians in clinical settings (OR, ER, critical care). System performs iso-centric scans; projections processed via GPU-based filtered back projection algorithm to generate 3D volumes. Synergy FP-CR software manages image acquisition, storage, and post-processing (MPR, volume rendering, metal artifact reduction). Output displayed on high-resolution monitors for intra-operative visualization and surgical navigation. Benefits include improved anatomical context for complex procedures, reduced scan times, and enhanced workflow efficiency. Device supports DICOM connectivity for PACS integration.
Clinical Evidence
Clinical evaluation involved independent reviews by specialists in Urology, Orthopedics, Gastroenterology, Cardiology, and Neurology. Specialists assessed 2D and 3D image quality across various anatomical regions (spine, extremities, vascular, GI, cardiac, neurological). Results confirmed diagnostic image quality sufficient for intended clinical applications and procedural requirements.
Technological Characteristics
Mobile C-arm; X-ray generator (15kW, 40-120kV); rotating anode X-ray tubes (RAD 15/RTM 70 HS); Amorphous Silicon or CMOS FPDs; GPU-based filtered back projection reconstruction; DICOM 3.0 compliant; Ethernet/wireless connectivity. Standards: IEC 60601-1 (safety), IEC 60601-1-2 (EMC), IEC 60601-2-54 (X-ray performance).
Indications for Use
Indicated for adult and pediatric patients requiring 2D and 3D fluoroscopic imaging for diagnostic, surgical, and interventional procedures including orthopedic, urologic, gastrointestinal, neurological, vascular, and critical care applications. Contraindicated during pregnancy.
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
- Digiscan FDX (K200218)
Reference Devices
Submission Summary (Full Text)
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**FDA** **U.S. FOOD & DRUG**
ADMINISTRATION
June 5, 2026
Allengers Medical Systems Limited
% Sanjeev Marjara
Managing Director
FDA Hall, Unit-2,
Bhankarpur, Mubarakpur Road, Derabassi, Distt Mohali
SAS NANGAR MOHALI, PUNJAB 140507
INDIA
Re: K253296
Trade/Device Name: Digital C-ARM with 3D
Regulation Number: 21 CFR 892.1650
Regulation Name: Image-Intensified Fluoroscopic X-Ray System
Regulatory Class: Class II
Product Code: OXO, JAA, OWB
Dated: May 8, 2026
Received: May 8, 2026
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 (the 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 available 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.
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-
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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
GABRIELA M. RODAL -S Digitally signed by GABRIELA M. RODAL -S for
Lu Jiang, Ph.D.
Assistant Director
Diagnostic X-Ray Systems Team
DHT8B: Division of Radiological Imaging
Devices and Electronic Products
OHT8: Office of Radiological Health
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
# Indications for Use
510(k) Number (if known)
K253296
Device Name
Digital C-ARM with 3D
Indications for Use (Describe)
Digiscan V30 3D is X-Ray based fluoroscopy equipment. It is intended for use in visualizing complex anatomical structures and procedures such as 3D Reconstruction, endoscopy Studies (ERCP), urology, Gastro, orthopedic, neurology, Fertility studies (HSG), cholangiography, vascular angiography with and without subtraction, critical care and emergency room procedures. This equipment produces real time images of anatomy using x-rays.
Exclusion:
Device is not meant for Mammography.
Contraindications of device:
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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K253296
# Allengers Medical Systems Limited
## 510(k) SUMMARY
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
Road, Derabassi, Distt Mohali-140507, India
Telephone No: +91 1762-282600
+919872980168
rnd@allengers.net
Contact Person: Sanjeev K. Marjara
Date Prepared: April 24, 2026
### 2. Proposed Device:
Device (trade) name: Digital C-ARM with 3D
Model Number: HF 59R
Series Name: Digiscan V30 3D
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: OXO, JAA, OWB
### 3. Predicate Device:
Device (trade) name: Digiscan FDX
510(K) Number : K200218
Clearance Date : August 7, 2022
Classification Name: Image-Intensified Fluoroscopic X-Ray System
Classification Panel: Radiology
Regulation Number : 21 CFR 892.1650
Device Class : Class II
Product Code: OXO, JAA, OWB
### 4. Reference Device :
#### Reference Device 1
Device (trade) name: Cios Spin
510(K) Number : K210054
Clearance Date : February 05, 2021
Classification Name: Image-Intensified Fluoroscopic X-Ray System,
Classification Panel: Radiology
Regulation Number : 21 CFR 892.1650
Device Class : Class II
Product Code: OXO, JAA, OWB
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K253296
## **Allengers Medical Systems Limited**
### Reference Device 2
Device (trade) name: Ziehm Vision RFD 3D
510(K) Number : K243303
Clearance Date : January 21, 2025
Classification Name: Image-Intensified Fluoroscopic X-Ray System,
Classification Panel: Radiology
Regulation Number : 21 CFR 892.1650
Device Class : Class II
Product Code: OXO, JAA, OWB
Allengers Medical Systems Ltd. Supplies Solid State X-Ray Image Detectors that have been previously cleared by FDA or tested and evaluated per guidance for submission of 510(K) for solid state X-Ray imaging devices. Table 1 provides the list of solid state detectors used with device
**Table 1 List of Solid State X-Ray Image Detectors**
| Solid State Detectors | 510(K) Numbers |
| --- | --- |
| Varex Imaging corporation – Paxscan 3030DXV | K200218 |
| Varex Imaging corporation – Paxscan 2020DXV | K200218 |
| MX Imaging – CFP 2222 | K200218 |
| MX Imaging – CFP 3131 | K200218 |
| IRAY Technology – Mercu 0909F | K200218 |
| Teledyne DALSA - Xineos-3030HS | K212336 |
| Allengers – FP3030HR | K220311 |
### 5. Device description:
The Digital C-ARM with 3D (Digiscan V30 3D) is a mobile X-Ray C-Arm fluoroscopic device used by radiation experts. Digiscan V30 3D is a digital fluoroscopic imaging system with Solid State X-Ray Image Detectors (FPD) used in diagnostic. The device is designed in such a way that it can be moved around and can be positioned for the required anatomical/clinical/procedural position.
Digiscan V30 3D composed of C-Arm, X-Ray generating equipment (X-Ray controller, high voltage generator, X-Ray tube), FPD, and workstation (Console computer and Monitor). C-Arm unit with generator is capable of movements which are essential for patient positioning, like horizontal travel, orbital movement, vertical movement and C rotation. The X-Ray generator, X-Ray control system and collimator controls are housed in the C-Arm unit.
**Synergy FP-CR** imaging software is a Digital Imaging System (DIS) designed for C-arm Fluoroscopic Mobile X-Ray System. Synergy FP-CR imaging software provides useful functions to manage X-Ray images obtained from Digiscan V30 3D FPD Fluoroscopic Mobile X-Ray System.
The following in Table 2 are the specific components for the system. A complete system will consist of a selection of one of the devices in each category.
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K253296
## *Allengers Medical Systems Limited*
Table 2 Combination Details
| Component | Manufacture | Model |
| --- | --- | --- |
| X-Ray Generator | Allengers | XGEN-C15 |
| X-Ray Tube | Varex Imaging | RAD15 |
| X-Ray Tube | I.A.E | RTM 70 HS |
| Solid State X-Ray Image Detectors | Varex Imaging | Paxscan 3030 DXV Paxscan 2020 DXV |
| Solid State X-Ray Image Detectors | IRAY Technology | Mercu 0909F |
| Solid State X-Ray Image Detectors | MX Imaging | CFP 2222 CFP 3131 |
| Solid State X-Ray Image Detectors | Teledyne DALSA | Xineos-3030HS |
| Solid State X-Ray Image Detectors | Allengers | FP3030HR |
### 6. Indications for Use:
Digiscan V30 3D is X-Ray based fluoroscopy equipment. It is intended for use in visualizing complex anatomical structures and procedures such as 3D Reconstruction, endoscopy Studies (ERCP), urology, Gastro, orthopedic, neurology, Fertility studies (HSG), cholangiography, vascular angiography with and without subtraction, critical care and emergency room procedures. This equipment produces real time images of anatomy using x-rays.
#### Exclusion:
Device is not meant for Mammography.
#### Contraindications of device:
Exposure of X-ray should be avoided during pregnancy.
### 7. Technological Characteristics Comparison to Predicate Devices:
The Digiscan V30 3D having set of components similar to the Digiscan FDX, Cios Spin and Ziehm Vision RFD 3D 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 devices.
### 8. Software Feature
The software feature set and functions are 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 V30 3D Mobile C-Arm X-Ray Machine is substantially equivalent to the commercially available Digiscan FDX (K200218), Cios Spin (K210054) and Ziehm Vision RFD 3D (K243303). Functional and specification differences are identifying in the following table.
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K253296
# Allengers Medical Systems Limited
Table 3: Functional and specification differences
| Feature | Digiscan V30 3D (Subject Device) | Digiscan FDX (Predicate Device) | Cios Spin (Reference Device 1) | Ziehm Vision RFD 3D (Reference Device 2) | Discussion of Difference |
| --- | --- | --- | --- | --- | --- |
| 510(k) | This submission | K200218 | K210054 | K243303 | -- |
| **2. Product Code** | | | | | |
| Product Classification Code | OXO, JAA, OWB | OXO, JAA, OWB | OXO, JAA, OWB | OWB | Same |
| **3. Classification** | | | | | |
| Classification | 21 CFR 892.1650 | 21 CFR 892.1650 | 21 CFR 892.1650 | 21 CFR 892.1650 | Same |
| **4. Intended Use** | | | | | |
| Indications for Use | Digiscan V30 3D is X-Ray based fluoroscopy equipment. It is intended for use in visualizing complex anatomical structures and procedures such as 3D Reconstruction, endoscopy Studies (ERCP), urology, Gastro, orthopedic, neurology, Fertility studies (HSG), cholangiography, vascular angiography with and without subtraction, critical care and emergency room procedures. This equipment produces real time images of anatomy using x-rays. **Exclusion:** This Machine is not meant for Mammography. | The Digiscan FDX 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 are 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. **Exclusion:** Digiscan FDX is not recommended for Mammography. **Contraindications:** Exposure of | The Cios Spin is a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications. Clinical applications may include but are not limited to: interventional fluoroscopic, gastro-intestinal, endoscopic, urologic, pain management, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The patient population may include pediatric patients. | The Ziehm Vision RFD 3D system is intended for use in providing both 2D and 3D medical imaging for all adult and pediatric populations, using pulsed and continuous fluoroscopic imaging. The device provides 2D medical imaging for fluoroscopy, digital subtraction, and acquisition of cine loops during diagnostic interventional and surgical procedures where intra-operative imaging and visualization of complex anatomical structures of both lower and higher contrast density are required. Such procedures may include but are not limited to those of interventional cardiology, heart surgery, hybrid procedures, interventional radiology, interventional angiography, electrophysiology, pediatrics, endoscopic, urological, gastroenterology, orthopedic, maxillofacial surgery, neurology, neurosurgery, critical care, emergency room procedures, and those procedures visualizing structures of the cervical, thoracic, and lumbar regions of the spine and joint fractures of the upper and lower extremities, and where digital image data is required for Computer-Assisted Surgery procedures. The device is also intended to provide 3D medical imaging of patients during orthopedic. | Essentially the same *Note:* There are no Differences between the subject device and the predicate & reference devices with respect to indication and intended use. |
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K253296
# Allengers Medical Systems Limited
| | Contraindications of device: Exposure of X-ray should be avoided during pregnancy. | X-Ray should be avoided during pregnancy. | | neurological, intra-operative surgical procedures and where the clinician benefits from 3D visualization of complex anatomical structures, such as but not limited to those of high contrast objects, bones, joints, maxillofacial, cervical, thoracic, and lumbar regions of the spine, pelvis, acetabulum and joint fractures of the upper and lower extremities, and where digital image and C-arm positioning data is required for Computer-Assisted Surgery procedures. The visualization of such anatomical structures assists the clinician in the clinical outcome. At the discretion of a physician, the device may be used for other imaging applications. This device does not support direct radiographic film exposures and is not intended for use in performing mammography. The system is not intended for use near MRI systems. | |
| --- | --- | --- | --- | --- | --- |
| 5. X-Ray Generator | | | | | |
| Type | Monoblock and High Frequency Generator | Monoblock and High Frequency Generator | Monoblock and High Frequency Generator | Monoblock and High Frequency Generator | Same |
| Kilowatt Rating | 15KW | 15KW | 12 kW Optional 25 kW | 25 kW/ 30KW | Same as Predicate device |
| KV Minimum | 40 KV | 40 KV | 40 KV | 40 KV | Same |
| KV Maximum | 120KV | 120KV | 125 KV | 120KV | Same as Predicate and Reference Device 2 |
| Dose Control System | Yes | Yes | Yes | Yes | Same |
| Dose Area Product | Yes | Yes | Yes | Yes | Same |
| 6. X-Ray Tube | | | | | |
| Model | RAD 15 | A145 | -- | -- | -- |
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K253296
# **Allengers Medical Systems Limited**
| Tube Type | Rotating Anode | Rotating Anode | Rotating Anode | Rotating Anode | Same |
| --- | --- | --- | --- | --- | --- |
| Cooling HU/min | 81000 HU/ min | 70000 HU/min | 91000 HU/min | 102000 HU/ min | Similar (SE #1) |
| Anode Heat Capacity | 365KHU | 300 KHU | 365 KHU | 365 KHU | Same as Reference Device 1 & 2. |
| Focal Spot Size, mm | Dual Focus 0.3/0.6 | Dual Focus 0.3/0.6 | Dual Focus 0.3/0.5 | Dual Focus 0.3/0.6 | Same as Predicate and Reference Device 2 |
| Maximum Tube Power rating , KW | 35kw | 25KW | 25 KW | Not publically available | Similar (SE #2) |
| Target Angle | 10° | 10° | 10° | Not publically available | Same |
| Optional Tube | | | | | |
| Model | RTM 70 HS | A145 | -- | -- | -- |
| Tube Type | Rotating Anode | Rotating Anode | Rotating Anode | Rotating Anode | Same |
| Cooling HU/min | 104000 HU/ min | 70000 HU/min | 91000 HU/min | 102000 HU/ min | Similar (SE #1) |
| Anode Heat Capacity | 300KHU | 300 KHU | 365 KHU | 365 KHU | Same as Predicate Device. |
| Focal Spot Size, mm | Dual Focus 0.3/0.6 | Dual Focus 0.3/0.6 | Dual Focus 0.3/0.5 | Dual Focus 0.3/0.6 | Same as Predicate and Reference Device 2 |
| Maximum Tube Power rating , KW | 45KW | 25KW | 25 KW | Not publically available | Similar (SE #2) |
| Target Angle | 10° | 10° | 10° | Not publically available | Same |
| 7. Radiographic Mode | | | | | |
| KV Range | 40-120 KV | 40-120 KV | 40-125 KV | 40-120 KV | Same as Predicate and Reference Device 2 |
| mA Range | 150 mA | Upto 150 mA | 10 mA to 120 mA (12KW) 10 mA to 250 mA (25KW) | 250mA/300mA | Same as Predicate Device |
| 8. Fluoroscopic Mode | | | | | |
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K253296
# **Allengers Medical Systems Limited**
| KV Range | 40-120 kV | 40-120 KV | 40-125 KV | 40-120 KV | Same as Predicate and Reference Device 2 |
| --- | --- | --- | --- | --- | --- |
| Pulse fluoroscopic | Yes | Yes | Yes | Yes | Same |
| ABS Control | Yes | Yes | Yes | Yes | Same |
| Snapshot Mode | Yes | Yes | Yes | Yes | Same |
| Max mA Range | Upto 60 mA | Upto 30 mA | 3 mA to 119 mA (12KW) 3 mA to 250 mA (25KW) | 0.2-250mA/ 0.2-300mA | Similar (SE #3) |
| Pulses per second (pps) (max) | Upto 15 (1536*1536), upto 30 (1024*1024) | Upto 15 (1536*1536), upto 30 (1024*1024) | 0.5 p/s to 30 p/s | 1p/s to 25 p/s | Same as Predicate Device. |
| 9. Solid State X-Ray Image Detectors | | | | | |
| Make | Varex's, Paxscan 3030 DXV | Varex's, Paxscan 3030 DXV | -- | 30 cm aSi FPD | -- |
| Type | Amorphous Silicon | Amorphous Silicon | CMOS with CsI scintillator | Amorphous Silicon | Same as Predicate and Reference Device 2 |
| Active Area | 298mm (h) x 298mm (v) (11.7 x 11.7 in) | 298mm (h) x 298mm (v) (11.7 x 11.7 in) | 300mmx300mm | 300mmx300mm | Same as Predicate Device. |
| Pixel Matrix | 1,536 (h) x 1,536 (v) | 1,536 (h) x 1,536 (v) | 1,952 (h) x 1,952 (v) | 1,536 (h) x 1,536 (v) | Same as Predicate and Reference Device 2 |
| DQE | 80% at 0lp/mm | 80% at 0lp/mm | 72% at 0lp/mm | Not publically available | Same as Predicate Device. |
| Modulation Transfer Function (MTF) | 55% at 1lp/mm | 55% at 1lp/mm | 58% at 1lp/mm | Not publically available | Same as Predicate Device. |
| A/D Conversion | 16 bit | 16 bit | 16 bit | Not publically available | Same |
| Pixel Pitch | 194μm | 194μm | 152μm | Not publically available | Same as Predicate Device. |
| Optional | | | | | |
| Make | Teledyne DALSA - Xineos-3030HS | MX CFP 3131 | -- | 31 cm CMOS FPD | -- |
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K253296
# Allengers Medical Systems Limited
| Type | CMOS | CMOS | CMOS | CMOS | Same |
| --- | --- | --- | --- | --- | --- |
| Active Area | 295mm (h) x 295mm (v) | 309.4mm (h) x 307.2mm (v) | 300mmx300mm | Not publically available | Similar (SE #4) |
| Pixel Matrix | 1,952 (h) x 1,952 (v) | 3094 (h) x 3072 (v) | 1,952 (h) x 1,952 (v) | Not publically available | Same as Reference Device 1. |
| DQE | 72% at 0lp/mm | 75% at 0lp/mm | 72% at 0lp/mm | Not publically available | Same as Reference Device 1. |
| Modulation Transfer Function (MTF) | 58% at 1lp/mm | 70% at 1lp/mm | 58% at 1lp/mm | Not publically available | Same as Reference Device 1. |
| A/D Conversion | 16 bit | 14 bit | 16 bit | Not publically available | Same as Reference Device 1. |
| Pixel Pitch | 152 μm | 100 μm | 152μm | Not publically available | Same as Reference Device 1. |
| Optional | | | | | |
| Make | Allengers -3030HR | Varex's , Paxscan 3030 DXV | -- | -- | -- |
| Type | Amorphous Silicon | Amorphous Silicon | NA | NA | Same as Predicate |
| Active Area | 307.2mm (h) x307.2mm (v) | 298mm (h) x 298mm (v) | NA | NA | Similar (SE #4) |
| Pixel Matrix | 2048 (h) x 2048 (v) | 1,536 (h) x 1,536 (v) | NA | NA | Similar (SE #5) |
| DQE | 80% at 0lp/mm | 80% at 0lp/mm | NA | NA | Same as Predicate device |
| Modulation Transfer Function (MTF) | 59% at 1lp/mm | 55% at 1lp/mm | NA | NA | Similar (SE #6) |
| A/D Conversion | 16 bit | 16 bit | NA | NA | Same |
| Pixel Pitch | 150μm | 194μm | NA | NA | Similar (SE #7) |
| Optional | | | | | |
| Make | MX CFP 3131 | MX CFP 3131 | -- | -- | -- |
| Type | CMOS | CMOS | NA | NA | Same |
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| Active Area | 309.4mm (h) x 307.2mm (v) | 309.4mm (h) x 307.2mm (v) | NA | NA | Same |
| --- | --- | --- | --- | --- | --- |
| Pixel Matrix | 3094 (h) x 3072 (v) | 3094 (h) x 3072 (v) | NA | NA | Same |
| DQE | 75% at 0lp/mm | 75% at 0lp/mm | NA | NA | Same |
| Modulation Transfer Function (MTF) | 70% at 1lp/mm | 70% at 1lp/mm | NA | NA | Same |
| A/D Conversion | 14 bit | 14 bit | NA | NA | Same |
| Pixel Pitch | 100 µm | 100 µm | NA | NA | Same |
| **Optional** | | | | | |
| Make | Varex's , Paxscan 2020 | Varex's , Paxscan 2020 | -- | -- | -- |
| Type | Amorphous Silicon | Amorphous Silicon | NA | Amorphous Silicon | Same |
| Active Area | 199mm (h) x 199mm (v) | 199mm (h) x 199mm (v) | NA | 203mm (h) x 203mm (v) | Same as Predicate device |
| Limiting resolution (Max) | 2.58 lp/mm | 2.58 lp/mm | NA | 3.1lp/mm | Same as Predicate Device |
| Pixel Matrix | 1,024 (h) x 1,024 (v) | 1,024 (h) x 1,024 (v) | NA | 1,024 (h) x 1,024 (v) | Same as Predicate Device |
| DQE | 80% at 0lp/mm | 80% at 1lp/mm | NA | 55% at 1lp/mm | Same as Predicate Device |
| Modulation Transfer Function (MTF) | 55% at 1lp/mm | 55% at 1lp/mm | NA | 55% at 1lp/mm | Same |
| A/D Conversion | 16 bit | 16 bit | NA | 16 bit | Same |
| Pixel Pitch | 194µm | 194µm | NA | 194µm | Same |
| **Optional** | | | | | |
| Make | IRAY 's, Mercu 0909F | IRAY 's, Mercu 0909F | -- | -- | -- |
| Type | Amorphous Silicon | Amorphous Silicon | NA | NA | Same |
| Active Area | 228.6mm (h)x228.6mm (v) | 228.6mm (h)x228.6mm (v) | NA | NA | Same |
| Pixel Matrix | 1,024 (h) x 1,024 (v) | 1,024 (h) x 1,024 (v) | NA | NA | Same |
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| DQE | 77% at 0lp/mm | 77% at 0lp/mm | NA | NA | Same |
| --- | --- | --- | --- | --- | --- |
| Modulation Transfer Function (MTF) | 64% at 1lp/mm | 64% at 1lp/mm | NA | NA | Same |
| A/D Conversion | 16 bit | 16 bit | NA | NA | Same |
| Pixel Pitch | 205µm | 205µm | NA | NA | Same |
| **Optional** | | | | | |
| Make | MX CFP 2222 | MX CFP 2222 | -- | -- | -- |
| Type | CMOS | CMOS | NA | NA | Same |
| Active Area | 217mm (h) x 217mm (v) | 217mm (h) x 217mm (v) | NA | NA | Same |
| Pixel Matrix | 2170 (h) x 2170 (v) | 2170 (h) x 2170 (v) | NA | NA | Same |
| DQE | 75% at 0lp/mm | 75% at 0lp/mm | NA | NA | Same |
| Modulation Transfer Function (MTF) | 70% at 1lp/mm | 70% at 1lp/mm | NA | NA | Same |
| A/D Conversion | 16 bit | 16 bit | NA | NA | Same |
| Pixel Pitch | 100 µm | 100 µm | NA | NA | Same |
| **10. Viewing Monitor(s)** | | | | | |
| Size, in | 27' & 32' (In Single Monitor) 19' & 21' (In dual Monitors) | 27' & 32' (In Single Monitor) 19' & 21' (In dual Monitors) | 19' TFT high-brightness color display | 19' Duo flat screen monitors or 32' UDH single flat screen monitor | Same as Predicate Device. |
| Touch Screen | Yes | Yes | Yes | Yes | Same. |
| **11. Touch Panel** | | | | | |
| Touch based control | Available | Available | Available | Available | Same. |
| **12. Collimator** | | | | | |
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| Collimator system | Available | Available | Available | Available | Same. |
| --- | --- | --- | --- | --- | --- |
| 13. Grid | | | | | |
| Grid Type | Removable | Removable | Removable | Removable | Same. |
| Lines | 70 lines /cm | 70 lines /cm | 80 lines /cm | 70 lines /cm | Same as Predicate Device & Reference Device 2. |
| Ratio | 8:1 | 8:1 | 15:1 | 8:1 | Same as Predicate Device & Reference Device 2. |
| 14. Image Processing and storage | | | | | |
| Imaging Mode | • Pulsed Fluoroscopy • Digital Spot | • Pulsed Fluoroscopy • Digital Spot | • Pulsed Fluoroscopy • Digital Spot | • Pulsed Fluoroscopy • Digital Spot | Same |
| Video storage type | Internal HDD drive, USB, CD/DVD-RW drive | Internal HDD drive, USB, CD/DVD-RW drive | Internal HDD drive, DVD drive for digital image storage on CD-R, | Internal HDD, USB and CD/DVDRW drive | Same |
| Image Interference | Detector Dependant | Detector Dependant | Detector Dependant | Detector Dependant | Same |
| Capacity Number of images | Upto 100,000 | Upto 100,000 | Upto 300,000 | Upto 100,000 | Same as Predicate & Reference Device 2. |
| Image matrix size | 1536*1536 Pixels 1024*1024 Pixels | 1536*1536 Pixels 1024*1024 Pixels | 1,952 x 1,952 pixel | 3,072 x 3,072 | Same as Predicate Device. |
| LIH | Yes | Yes | Yes | Yes | Same |
| Dicom conformance | Yes | Yes | Yes | Yes | Same |
| PACS Interfaces | Wired or Wireless on Ethernet | Wired or Wireless on Ethernet | Wired or Wireless on Ethernet | Wired or Wireless on Ethernet | Same |
| Hard copy devices | Printer and DICOM print | Printer and DICOM print | Printer and DICOM print | Printer and DICOM print | Same |
| 3D Imaging | | | | | |
| Scan technology | Iso-centric scan technology | N/A | Iso-centric scan technology | Iso-centric scan technology | Same. |
| Projections for 3D reconstruction | Up to 514 | N/A | Up to 400 | up to 400 images | Similar (SE #8) |
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| 3D volume size | 18.5 x 18.5 x 18.5 cm | N/A | 16 x 16 x 16 cm | 16 x 16 x 16 cm | Similar (SE #9) |
| --- | --- | --- | --- | --- | --- |
| 3D volume resolution | 726 x 726 x 726 voxels | N/A | 512 x 512 x 512 voxels | 512 x 512 x 512 voxels | Similar (SE #10) |
| Scan speed | Less than 20 seconds | N/A | 30 seconds | 48 seconds | Similar (SE #11) |
| Orientation & 3D viewing modes | • Multiplanar reconstruction (MPR) • Simultaneous display of 3 projections (axial, coronal, and sagittal) • Single Cut • Double Cut • 2D Cell | N/A | • Simultaneous display of 3 projections (transversal, coronal, and sagittal) • MPR | MPR (Axial / Coronal / Sagittal) | Same |
| 3D power scan option for obese patients | Yes | N/A | Yes | Yes | Same |
| 3D volume rendering | • Volume rendering techniques VRT • Shaded surface display (SSD) • Maximum intensity projection ( Max IP) • Minimum intensity projection ( Max IP) MRP Slab | N/A | Volume rendering technique (VRT) | • Volume rendering techniques VRT • Surface rendering | Same |
| Metal artifact reduction | Yes | N/A | Yes | Yes | Same |
| Navigation interface | Yes | N/A | Yes | Yes | Same |
| Image Matrix | 1536 x1536 | N/A | 1952 x 1952 pixels | 3,072 x 3,072 | Similar (SE #12) |
| FOV | 18.5 cm | N/A | 16 cm | 16 cm | Similar (SE #13) |
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| General Functionality of 3D Viewer (Post process feature) | • MPR navigation (Segital, coronel and Axial) • Volume rotation • Slice navigation • Window level • Move volume/plane • Rotate volume /plane • Zoom/Pan | N/A | • MPR navigation, • distance & angle measurement, • annotations, • volume rotation, • slice navigation | • MPR, • measurement, • segmentation • Zoom | Same |
| --- | --- | --- | --- | --- | --- |
| Reconstruction Algorithm | GPU-based Filtered Back Projection | N/A | FDK-based filtered back projection | Cone Beam CT reconstruction | Similar (SE #14) |
| Matrix size per slice | 514 x 514 pixels | N/A | 512 x 512 pixels | 512 x 512 pixels | Similar (SE #15) |
| Voxel pitch | 0.3 mm isotropic resolution | N/A | 0.3 mm isotropic voxel | 0.31 mm | Same |
| Applied Features | • Lag Correction • Noise Filtering • Beam Hardening Correction • Metal Artifact Correction | N/A | • Noise Filtering • Beam Hardening Correction • Metal Artifact Correction | • Noise Filtering • Beam Hardening Correction • Metal Artifact Correction | Same |
| Number of Projections per Revolution | 180 | N/A | Up to 400 projections | Up to 400 projections | Similar (SE #16) |
| Angular Increment | 1° per projection | N/A | ~0.5° per projection (approx.) | ~0.45° per projection (approx.) | Similar (SE #17) |
| Rotation Trajectory | -90° to +90° (total angular span = 180°) | N/A | -100° to +100° (Circular orbital trajectory ~200°) | -90° to +90° (Orbital rotation ~180°) | Same as Reference Device 2 |
| Rotation Speed | 10 degree/Sec | N/A | ~6.7 degree/Sec | ~3.75 degree/Sec | Similar (SE #18) |
| Reconstructed Volume Size: | 17.7 cm x 17.7 cm x 15.4 cm | N/A | 16 cm x 16 cm x 16 cm | 16 cm x 16 cm x 16 cm | Similar (SE #19) |
| **15. Power Requirement** | | | | | |
| Power Requirement | 110/230 Vac,(±10% ) 50/60 Hz | 110/230 Vac,(±10% ) 50/60 Hz | 110/230 Vac,(±10% ) 50/60 Hz | 100/240 Vac,(±10% ) 50/60 Hz | Same |
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Difference Discussion
| SE- # | Substantial Equivalence discussion |
| --- | --- |
| SE #1, #2 | **#1, #2** There are many X-Ray tubes available due to equipment design considerations. The tubes were tested and information is included in the Operator and Service Manuals. Any differences between the subject device and predicate & reference devices do not change or add new potential safety risks. Therefore, it is our determination that there is "No impact on safety or efficacy" and there are no new potential or increased safety risks concerning this difference. |
| SE#3 | **#3** The differences in the X-Ray current produced by the generators made by Allengers do not raise any new questions of safety and effectiveness between the subject and Predicate & reference devices, as the subject device has successfully passed electrical safety testing per IEC 60601-1, and IEC 60601-2-54. |
| SE#04, #05, #06 & #07 | **#04, #05, #06 & #07** The Subject device utilized different Solid State X-Ray Image Detectors (FPD) as compare to reference devices- Digiscan FDX, Cios Fusion, Ziehm Vision RFD 3D, however Detector technology is comparable to predicate and reference devices as per the SSXI Guidance document .The FPD used along with subject device are already cleared by FDA and does not raise the level of safety concern and affect any effectiveness. The relevant 510(k) approval numbers are K200218, K210054, K243303. |
| SE#08 | **#08** Using higher projections in 3D reconstruction improves workflow efficiency by accelerating throughput in high-volume imaging centers. It also reduces system wear and energy consumption, making it especially valuable in spine and orthopedic |
| SE#9 | **#09** A larger Field of View (FOV) in 3D scanning enables expanded anatomical coverage, allowing more of the body to be captured in a single acquisition. This minimizes the need for multiple scans or patient repositioning—an essential advantage in procedures like L-Spine screw placement, where precise alignment and uninterrupted anatomical context are critical for effective surgical navigation |
| SE#10 | **#10** Higher resolution (591X591X514) gives more details therefore it captures finer anatomical detail and Better for advanced post-processing (e.g., segmentation, 3D reconstruction etc) |
| SE#11 | **#11** Shorter scan time enhances patient comfort and compliance, while significantly improving surgical workflow efficiency—particularly in time-sensitive procedures where rapid imaging supports precise planning and execution |
| SE#12 & #15 | **#12 & #15** The differences in Image Matrix (1536 x 1536) and Matrix size per slice (591X591) represent an optimization of the reconstruction pipeline. These parameters ensure that the spatial resolution is maximized for the specific detector used in the subject device without introducing artifacts or compromising the diagnostic integrity compared to the predicate devices. |
| SE#13 | **#13** The Subject Device features a larger Field of View (FOV) of 18.5 cm compared to the 16 cm FOV of the reference devices. As noted in the clinical discussion, a larger FOV enables expanded anatomical coverage in a single acquisition, which is particularly beneficial for spine and pelvic procedures |
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| SE#14 | **#14** The use of a GPU-based Filtered Back Projection reconstruction algorithm is technically equivalent to the FDK-based or Cone Beam CT algorithms used by the predicates. The use of GPU acceleration allows for faster processing of the higher-resolution voxel grid while maintaining the same fundamental filtered back-projection principle |
| --- | --- |
| SE#16, #17 & #18 | **#16, #17 & #18** The subject device utilizes 180 projections per revolution with an angular increment of 1°, whereas predicates use up to 400 projections. While the number of projections is lower, this is a deliberate design choice to reduce total X-ray dose and system wear while still providing sufficient data for high-quality 3D reconstruction in orthopedic and neurosurgical applications |
| SE#19 | **#19** The Reconstructed Volume Size (17.7 x 17.7 x 15.4 cm) is slightly larger than the reference devices (16 x 16 x 16 cm). This difference is a result of the larger detector active area and does not introduce new safety risks; rather, it enhances clinical utility by providing more anatomical context |
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10. Technological characteristics comparison to predicate & reference devices:
The indications for use, operating principle, technical specifications such as X-Ray tube head and generator as well as safety characteristics of Digiscan V30 3D are identical to those of the predicate & reference devices. Digiscan V30 3D is designed as a set of components (X-Ray tube and housing, detector, digital imaging system, collimator, generator etc.) similar to the predicate & reference device Digiscan FDX (K200218), Cios Spin (K210054) and Ziehm Vision RFD 3D (K243303). Based on the recognized standard conformity evidences related to electro-mechanical, software-, and risk management, Allengers Medical Systems certifies that technological characteristics of Digiscan V30 3D are substantially equivalent to Digiscan FDX, Cios Spin and Ziehm Vision RFD 3D, the predicate & reference devices.
The Digital C-ARM with 3D mobile X-Ray C-Arm is a set of components similar to the predicate & reference devices as compared in table 3 of this 510(K) summary. This table above show that the system are either similar or the same, as the predicate & reference devices.
11. Performance Testing
Testing for verification and validation of the device was found acceptable to support the claims of substantial equivalence. Performance testing included functional evaluation of all motions systems against design specifications. Additional engineering bench testing was performed including: the non-clinical testing identified in the guidance for submission of 510(k)s for Solid state X-Ray imaging devices (SSXI). System performance demonstration and imaging performance evaluation were also conducted. Safety compliance was assessed according to IEC 60601-1: 2020. Allengers Medical Systems Ltd certifies conformance to Voluntary standards covering electrical and Mechanical safety.
Bench testing was further performed to characterize and demonstrate the 3D imaging capability with FPDs. So, comprehensive system-level testing, including 3D image quality and dose characterization, has been performed. This included evaluation of critical performance parameters such as
- C-arm or gantry positioning accuracy
- In-plane uniformity assessment
- Spatial resolution with Modulation Transfer Function (MTF) in x-y plane
- Reconstruction section thickness characterization
- Noise measurements (pixel standard deviation in x-y plane or 2D noise power spectrum)
- Contrast to noise ratio (CNR) assessment
- Radiation dose measurements (CTDI and DLP)
- Metal Artifact Reduction
These parameters were successfully characterized to justify that the Digiscan V30 3D device fulfills the requirements for 3D imaging capabilities.
In Conclusion: Performance testing activities confirmed that device requirements were met, system functionality is consistent with user needs and intended uses, and the device performs as designed without raising new questions regarding safety or effectiveness. Therefore, when compared to predicate devices, the Digiscan V30 3D supports a determination of substantial equivalence. It is the opinion of Allengers Medical Systems Ltd. that the Digital C-ARM with 3D is as safe and effective as the predicate and reference devices.
12. Software Features and Testing:
Software documentation prepared at the Basic Documentation Level, in accordance with FDA's guidance document "Guidance for the Content of Premarket Submissions for Device Software Functions", is included as part of this submission. This documentation provides detailed information on software architecture, design specifications, verification and validation activities, and risk management processes to demonstrate that the software functions perform as intended and support the overall safety and effectiveness of the device.
In addition, cybersecurity considerations have been addressed in alignment with FDA recommendations and international best practices.
Conclusion: The inclusion of software documentation at the Basic Documentation Level, together with a proactive cybersecurity risk management framework, ensures that the Digital C-ARM with 3D meets regulatory expectations for both functional performance and protection against cybersecurity vulnerabilities.
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### 13. Description of Non Clinical tests
Non Clinical performance testing has been performed on the Digiscan V30 3D machine and it demonstrates compliance with the following relevant voluntary FDA Recognized Consensus Standards as listed in the table below:
| Recognition Number | Product Area | Title of standard | Reference Number and date | Standard Development organization |
| --- | --- | --- | --- | --- |
| 19-49 | General | Medical Electrical Equipment – Part 1: General requirements for basic safety and essential performance | 60601-1 Edition 3.2 2020-08 Consolidated Version | IEC |
| 19-36 | General | Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic Compatibility – Requirements and tests | 60601-1-2 Edition 4.0 2014 [Including AMD 1:2021] | ANSI AAMI IEC |
| 12-336 | Radiology | Medical Electrical Equipment Part 1-3: General Requirements for Basic Safety and Essential Performance.- Collateral Standard: Radiation Protection in Diagnostic X-Ray Equipment. | 60601-1-3 Edition 2.2 2021-01 CONSOLIDATED VERSION | IEC |
| 12-309 | Radiology | Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis | 60601-2-28 Edition 3.0 2017-06 | IEC |
| 12-351 | Radiology | Particular requirements for the safety of X-Ray equipment for interventional procedures | 60601-2-43 Edition 3.0, 2022 | IEC |
| 12-348 | Radiology | Medical Electrical Equipment- Part 2-54: Particular Requirements for the Basic Safety and Essential Performance of X-Ray Equipment for Radiography and Radioscopy | 60601-2-54, (Edition 2.0 2022). | IEC |
| 13-79 | General | Medical device software – Software life cycle processes | 62304 (Edition 1.1, 2015) | IEC |
| 5-132 | General | Medical Electrical Equipment Part 1-6: General Requirements• for Basic Safety and Essential Performance- Collateral Standard: Usability | 60601-1-6, Edition 3.2 2020-07 CONSOLIDATED VERSION | IEC |
| 5-129 | General | Application of Usability Engineering to Medical Devices | 62366-1 015+AMD1:2020 | IEC |
| 5-125 | General I (QS/RM) | Medical devices – application of risk management to medical devices | 14971 Third Edition 2019-12 | ISO |
| 12-273 | Radiology | Safety of laser products – Part 1: Equipment classification, and requirements | 60825-1 Edition 2.0 2007-03 | IEC |
| 5-134 | General I (QS/RM) | ISO 15223-1 Fourth edition 2021-07 Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements | 15223-1 Fourth edition 2021-07 | ISO |
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**Table 4: FDA Guidance Documents**
| FDA Guidance Documents and Effective Date | |
| --- | --- |
| 1 | Guidance for Industry and FDA Staff – User Fees and Refunds for Premarket Notification Submissions 510(k) Document issued on October 5, 2022 |
| 2 | Guidance for Industry and Food and Drug Administration Staff: Electronic Submission Template for Medical Device 510(k) Submissions Document issued on October 2, 2023. |
| 3 | Guidance for Industry and FDA Staff: Format for Traditional and Abbreviated 510(k)s - Guidance for Industry and FDA Staff Document issued on September 13, 2019. |
| 4 | Guidance for Industry and Food and Drug Administration Staff: The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] Document Issued on July 28, 2014 |
| 5 | Guidance for Industry and FDA Staff: Guidance for the Submission Of 510(k)'s for Solid State X-ray Imaging Devices Document issued on September 1, 2016 |
| 6 | Guidance for Industry and FDA Staff: Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions Document Issued on June 27, 2025 |
| 7 | Guidance for Industry and FDA Staff: Off-The-Shelf Software Use in Medical Devices Document issued on August 11, 2023. |
| 8 | Guidance for Industry and FDA Staff: Applying Human Factors and Usability Engineering to Medical Devices. Document issued February 3, 2016 |
| 9 | Guidance for Industry and FDA Staff: Pediatric Information for X-ray Imaging Device Premarket Notifications. Document issued on November 28, 2017 |
| 10 | Guidance for Industry and FDA Staff: Electromagnetic Compatibility (EMC) of Medical Device Document issued on June 6, 2022 |
| 11 | Guidance for Industry and FDA Staff: Content of Premarket Submission for Device Software Functions Document issued on June 14, 2023. |
Non-clinical verification test results demonstrate that the Digiscan V30 3D complies with the aforementioned international and FDA recognized consensus standards and FDA guidance documents.
### **14. Description of clinical tests**
Independent clinical evaluations were obtained from specialists in Urology, Orthopedics, Gastroenterology, Cardiology, and Neurology. Each specialist reviewed the imaging performance, and the acquired 2D and 3D images were determined to be of adequate diagnostic quality for the indicated clinical applications.
The acquired images included examinations of:
- • Lumbar Spine (2D & 3D)
- • Cervical Spine (2D & 3D)
- • Orthopedic Spine (2D & 3D)
- • Vascular imaging
- • Extremities
- • Gastrointestinal imaging
- • Orthopedic procedures
- • Digital spot imaging
- • Fluoroscopic LIH (Last Image Hold) sequences
- • Cardiac imaging
- • Neurological imaging
- • Urological imaging
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The validation activities confirmed that the device consistently produced images of sufficient diagnostic quality across these anatomical regions and procedural applications. The results demonstrated that the system is safe and effective for its intended use.
**In Conclusion:** The Digital C-ARM with 3D was found to provide adequate image quality for the specific views and procedures identified in the Instructions for Use (IFU). Independent expert reviews and validation testing support that the device fulfills its intended imaging performance requirements, thereby reinforcing its safety and effectiveness profile.
### **15. Substantial Equivalence Conclusion:**
Digital C-ARM with 3D does not introduce any new indications for use, nor does the use of the systems result in any new potential hazards. The Digital C-ARM with 3D, the subject device is substantially equivalent to the predicate & reference devices, Digiscan FDX (K200218), Cios Spin (K210054) and Ziehm Vision RFD 3D (K243303). The intended use, the design principle, and the applicable standards for the subject device are identical to those of the predicate & reference devices. Some characteristics, for example, their appearance, the user interfaces and the physical dimensions are different. However, the performance test and non-clinical consideration result demonstrate that these differences do not raise any new questions of safety and effectiveness. Therefore, it is the Allengers opinion that the subject device appears to be as safe and effective as the predicate & reference devices.
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