Who is the manufacturer of Skanmobile, Skanmobile-Dr?

Skanray Technologies Limited filed the 510(k) submission for Skanmobile, Skanmobile-Dr (K212940).

What is the FDA product code for Skanmobile, Skanmobile-Dr?

IZL. It is classified under 21 CFR 892.1720 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for Skanmobile, Skanmobile-Dr?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Skanmobile, Skanmobile-Dr?

AMADEO M-DR mini, AMADEO M-AX mini (K182317); DRAGON X SPSL4HC; DRAGON X SPSL8HC (K173299).

Who can help prepare an FDA 510(k) submission like Skanmobile, Skanmobile-Dr?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Skanmobile, Skanmobile-Dr

K212940 · Skanray Technologies Limited · IZL · Mar 4, 2022 · Radiology

Device Facts

Record ID	K212940
Device Name	Skanmobile, Skanmobile-Dr
Applicant	Skanray Technologies Limited
Product Code	IZL · Radiology
Decision Date	Mar 4, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1720
Device Class	Class 2
Attributes	Pediatric

Intended Use

SKANMOBILE and SKANMOBILE-DR are intended for use in generating radio graphic images of human anatomy in all general-purpose x-ray diagnostic procedures for all patient population including paediatrics and adults. It may be used in radiology departments, emergency rooms, intensive care units, operating rooms, orthopaedics clinics, military camps, paediatric clinics, medical camps and small hospitals. SKANMOBILE and SKANMOBILE-DR are indicated for taking radiographic exposures of the skull, spinal column, chest, abdomen, extremities and other body parts with the patient sitting, standing or lying in the prone or supine position. The device has been designed for indoor usage and used/operated only by the trained & qualified physicians or x-ray technologist. SKANMOBILE and SKANMOBILE-DR are not intended for mammographic applications.

Device Story

Mobile X-ray system (SKANMOBILE/SKANMOBILE-DR) generates high-frequency X-rays for diagnostic radiography. Input: X-ray exposure parameters set by operator; Output: Radiographic images. System comprises tube head, trolley, and (for DR variant) wireless flat panel detector and touchscreen console. Used in hospitals/clinics by trained physicians or X-ray technologists. Device uses feedback circuits for output accuracy/reproducibility. Healthcare providers use images for diagnosis and treatment guidance. Benefits include portable diagnostic imaging capability in various clinical environments.

Clinical Evidence

No clinical data. Bench testing only. Compliance with performance standards (IEC 60601 series, etc.) and verification/validation of software and hardware components were sufficient to support safety and effectiveness per FDA guidance for solid-state X-ray imaging devices.

Technological Characteristics

High-frequency X-ray generator; 230/110 VAC power; manual collimator with LED light; wireless flat panel detectors (CsI technology); touchscreen console (DR variant). Connectivity via Wi-Fi/Ethernet. Complies with IEC 60601-1, 60601-1-2, 60601-1-3, 60601-2-54, 60601-2-28, and DICOM standards. Software follows ISO 62304.

Indications for Use

Indicated for radiographic imaging of human anatomy (skull, spine, chest, abdomen, extremities) in pediatric and adult patients. Used in clinical settings (radiology, ER, ICU, OR, etc.) by trained physicians or technologists. Not for mammography.

Regulatory Classification

Identification

A mobile x-ray system is a transportable device system intended to be used to generate and control x-ray for diagnostic procedures. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

AMADEO M-DR mini, AMADEO M-AX mini (K182317)
DRAGON X SPSL4HC; DRAGON X SPSL8HC (K173299)

Reference Devices

Ralco R72S (K030487)
Nexus DR Digital X-ray Imaging System with PaxScan 4336Wv4 (K161459)
CareView 1500P X-ray Flat Panel Detectors (K162178)
PerkinElmer XRpad2 4336 detector (K161966)
XenOR 35CW (CareView1500CW) (K150929)
Toshiba FDX3543RP or FDX3543RPW (K130883)
E-COM software (K193644)

Related Devices

K111725 — MOBILEDIAGNOST WDR · Sedecal., Sa. · Jul 19, 2011
K201340 — AQUILA 320 D / AQUILA 320 S · Vmi Tecnologias Ltda · Jun 19, 2020
K021016 — AMX-4 PLUS MOBILE X-RAY SYSTEM · GE Medical Systems · Jun 17, 2002
K043002 — SEDECAL MOBILE X-RAY UNITS WITH DIGITAL DETECTOR · Sedecal., Sa. · Nov 18, 2004
K212134 — Diagnostic X-ray System/PLX5200A · Nanjing Perlove Medical Equipment Co., Ltd. · Aug 25, 2021

Submission Summary (Full Text)

{0}------------------------------------------------ March 4, 2022 Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. Skanray Technologies Limited % Ankur Naik Managing Director IZiel Healthcare 14, Hadapsar Industrial Estate, Hadapsar Pune, Maharashtra 411013 INDIA Re: K212940 Trade/Device Name: SKANMOBILE, SKANMOBILE-DR Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: Class II Product Code: IZL, MQB Dated: January 12, 2022 Received: January 18, 2022 Dear Ankur Naik: 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 {1}------------------------------------------------ requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 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 (OS) 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@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Laurel Burk Assistant Director Diagnostic X-ray Systems Team 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 {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K212940 Device Name SKANMOBILE and SKANMOBILE-DR #### Indications for Use (Describe) SKANMOBILE and SKANMOBILE-DR are intended for use in generating radio graphic images of human anatomy in all general-purpose x-ray diagnostic procedures for all patient population including paediatrics and adults. It may be used in radiology departments, emergency rooms, intensive care units, operating rooms, orthopaedics clinics, military camps, paediatric clinics, medical camps and small hospitals. SKANMOBILE and SKANMOBILE-DR are indicated for taking radiographic exposures of the skull, spinal column, chest, abdomen, extremities and other body parts with the patient sitting or lying in the prone or supine position. The device has been designed for indoor usage and used/operated only by the trained & qualified physicians or x-ray technologist. SKANMOBILE and SKANMOBILE-DR are not intended for mammographic applications. Type of Use (Select one or both, as applicable) | ☒ Remediation Use (Part 264 CFR 90 Subpart D) | ☐ Gas Treatment Use (264 CFR 90 Subpart O) | |------------------------------------------------------------------------------------------------|--------------------------------------------| |------------------------------------------------------------------------------------------------|--------------------------------------------| |X Prescription Use (Part 21 CFR 801 Subpart D) | | Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Attachment 2-1: 005_510(k) Summary {4}------------------------------------------------ # 510(k) Summary - K212940 510(k) summary of safety and effectiveness for SKANMOBILE and SKANMOBILE-DR is provided in accordance with 21 CFR 807.92. | Date: | 12 January 2022 | |------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter (Owner): | Vasundhara R Regulatory Head Skanray Technologies Limited Plot# 15-17, Hebbal Industrial Area, Hebbal Mysore, Karnataka 570016, India P: +91 821 2415559 Email: vasundhara.r@skanray.com | | 510(k) Contact Person: | Ankur Naik Managing Director IZiel Healthcare 14, Hadapsar Industrial Estate, Hadapsar, Pune – 411013, India. P: +91 72762 2555 M: +91 7069553814 Email: ankur.naik@izielhealthcare.com | | Device Trade Name: | SKANMOBILE SKANMOBILE-DR | | Regulation Number: | 892.1720 | | Regulation Name: | Mobile X-Ray System | | Regulation Description: | A mobile x-ray system is a transportable device system intended to be used to generate and control x-ray for diagnostic procedures. This generic type of device may include signal analysis and display equipment, patient and equipment support, component parts, and accessories. | | Review Panel: | Radiology | | Device Class: | Class II | | Product Code: | IZL MQB | | Predicate Device(s): | ● AMADEO M-DR mini, AMADEO M-AX mini (K182317) Regulation number: 892.1720 Regulation name: Mobile X-Ray system Device class: II Product code: IZL, MQB Review Panel: Radiology | | • DRAGON X SPSL4HC; DRAGON X SPSL8HC (K173299) | | | Regulation number: 892.1720 | | | Regulation name: Mobile X-Ray system | | | Device Class: II | | | Product code: IZL, MQB | | | Review Panel: Radiology | | {5}------------------------------------------------ ### Device description The SKANMOBILE and SKANMOBILE-DR are X-ray systems which generates high frequency X-rays for diagnostic radiography in all patient population including pediatrics and adults. #### Device variants The following table lists the details of the variants of SKANMOBILE and SKANMOBILE-DR: #### Table 1: List of Device Variants | Product Name | Part # | |-----------------------------------------------------|---------------| | SKANMOBILE - HF diagnostic X-ray system, 230 VAC | 303-000018-0 | | SKANMOBILE - HF diagnostic X-ray system, 110 VAC | 303-000018-3 | | SKANMOBILE-DR – HF diagnostic X-Ray system, 230 VAC | 303-000018-15 | | SKANMOBILE-DR – HF diagnostic X-Ray system, 110 VAC | 303-000018-16 | ### Device design SKANMOBILE houses two microprocessors: one for control/supervisory functions and another for man-machine/user interface. The technology incorporates feedback circuits to ensure accuracy & reproducibility of X-Ray output. SKANMOBILE consists of following sub-assemblies: - 1. Tube head - 2. SKANMOBILE trolley SKANMOBILE-DR is a variant based on SKANMOBILE platform. SKANMOBILE-DR is a digital radiographic system designed for optimized image quality featuring wireless flat panel detector and operator console for digital imaging integrated with high frequency generator. SKANMOBILE-DR is similar to SKANMOBILE where tube head generator, collimator, and counter balancing mechanism remains same. The new or modified assemblies/sub-assemblies that are used in SKANMOBILE-DR are as follows: {6}------------------------------------------------ - 1. Touchscreen operator console. - 2. Modified brake mechanism for wheels - 3. Modified cassette tray to house the cassette / flat panel detectors. Both SKANMOBILE and SKANMOBILE-DR consists of software/firmware which enables the operation of the devices. The design and development of the software has been executed as per the requirements of ISO 62304. User interface is provided via UART interface from Console System. Software Control System of Control Firmware is of Master – Slave in nature. The programming language adopted is ANSI C and the software architecture follows a simple Call and Return flow of statements and modules. ### Flat panel detectors and image acquisition software integration details Table 2 explains the compatibility between available options of flat panel detectors and image acquisition software used in the X-ray systems. | Flat Panel Detector | Image Acquisition Software | Remarks | |----------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | CE certified / FDA cleared Compatible Flat Panel Detector Varex Paxscan 4336Wv4 can be used with the X-Ray system | FDA cleared Image Acquisition System with compatible Flat Panel Detector can be used. | SKANMOBILE-DR is verified and validated with Varex Flat Panel Detector Paxscan 4336Wv4 and ECOM Image Acquisition Software with customized OEM title | | CE certified / FDA cleared Compatible Flat Panel Detector CareView 1500P can be used with the X-ray system | FDA cleared Image Acquisition System with compatible Flat Panel Detector can be used. | SKANMOBILE-DR is verified and validated with CareView 1500P detector and ECOM Image Acquisition Software with customized OEM title | #### Table 2: Flat panel detectors and image acquisition software integration The above-mentioned specific combinations of flat panel detectors and image acquisition software are compatible with all types/configurations of other components (x-ray generator, x-ray tube, collimator, and mechanicals). The device is packaged inside a corrugated box with, appropriate labels and the user manual after cleaning the entire unit. The device is secured to the wooden pallet and covered for adequate safety. The device is packed appropriately as required by the mode of transportation. # Intended Use / Indications for Use SKANMOBILE and SKANMOBILE-DR are intended for use in generating radio graphic images of human anatomy in all general-purpose x-ray diagnostic procedures for all patient population including paediatrics and adults. It may be used in radiology {7}------------------------------------------------ departments, emergency rooms, intensive care units, operating rooms, orthopaedics clinics, military camps, paediatric clinics, medical camps and small hospitals. SKANMOBILE and SKANMOBILE-DR are indicated for taking radiographic exposures of the skull, spinal column, chest, abdomen, extremities and other body parts with the patient sitting, standing or lying in the prone or supine position. The device has been designed for indoor usage and used/operated only by the trained & qualified physicians or x-ray technologist. SKANMOBILE and SKANMOBILE-DR are not intended for mammographic applications. #### Comparison to predicate devices Two predicate devices are selected in this submission for the SKANMOBILE and SKANMOBILE-DR. Predicate device 1: AMADEO M-DR mini, AMADEO M-AX mini (K182317) Predicate device 2: DRAGON X SPSL4HC; DRAGON X SPSL8HC (K173299) The details of the substantial equivalence between the subject device and predicate devices are explained in Table 3: {8}------------------------------------------------ # Table 3: Comparison to Predicate Devices | Comparable Properties | Subject Device | Predicate Device 1 (K182317) | Predicate Device 2 (K173299) | Comparison Results | |-----------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Product name | SKANMOBILE and SKANMOBILE-DR | AMADEO M-DR mini, AMADEO M-AX mini | DRAGON X SPSL4HC; DRAGON X SPSL8HC | Not applicable | | Manufacturer | Skanray Technologies Limited | Oehm Und Rehbein Gmbh | Sedecal SA | Not applicable | | Regulation number | 892.1720 | 892.1720 | 892.1720 | Identical | | Product code | IZL, MQB | IZL, MQB | IZL, MQB | Identical | | Product Class | II | II | II | Identical | | Comparable Properties | Subject Device | Predicate Device 1 (K182317) | Predicate Device 2 (K173299) | Comparison Results | | Intended Use / Indications for Use | SKANMOBILE and SKANMOBILE-DR are intended for use in generating radio graphic images of human anatomy in all general-purpose x-ray diagnostic procedures for all patient population including paediatrics and adults. It may be used in radiology departments, emergency rooms, intensive care units, operating rooms, orthopaedics clinics, military camps, paediatric clinics, medical camps and small hospitals. SKANMOBILE and SKANMOBILE-DR are indicated for taking radiographic exposures of the skull, spinal column, chest, abdomen, extremities and other body parts with the patient sitting, standing or lying in the prone or supine position. The device has been designed for indoor usage and used/operated only by the trained & qualified physicians or x-ray technologist. SKANMOBILE and SKANMOBILE-DR are not intended for mammographic applications. | These Portable Diagnostic Radiographic Systems are intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. (Not for mammography). | These Portable Diagnostic Radiographic Systems are intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. (Not for mammography). | Substantially Equivalent | | Comparable Properties | Subject Device | Predicate Device 1 (K182317) | Predicate Device 2 (K173299) | Comparison Results | | Line power requirements | 230 VAC / 110 VAC | 100-240 VAC | 100-240 VAC / 220 - 240 VAC | Substantially Equivalent Mains power voltage range are country specific. Devices are designed to accept either 230VAC/220VAC or 100VAC/110VAC, depending on where they are placed. The mains input labelling will be declared to indicate the device compliance to the mains input meeting specified country mains regulation and hence does not raise the level of safety concern and affect performance. | | Generator type | High Frequency | High frequency | High frequency | Identical | | Comparable Properties | Subject Device | Predicate Device 1 (K182317) | Predicate Device 2 (K173299) | Comparison Results | | Generator power level | 4 KW | 5KW | 4KW, 8KW | Substantially equivalent Maximum generator power is the maximum power derived from the maximum kV and mA drawn. The device generates kV and mA optimal for the different anatomy as defined by the accepted anatomically programmed radiography (APR) table, which are independent of power drawn by the system. Thus, minor difference in the power does not change the intended application. Additionally, electrical safety and EMC testing has been performed on the subject devices and it has been observed that the device performs as intended and hence does not raise the level of safety concern and affect performance. | | Comparable Properties | Subject Device | Predicate Device 1 (K182317) | Predicate Device 2 (K173299) | Comparison Results | | Peak voltage | 100 kV | 110 kV | 125 kV | Substantially equivalent Minor difference in the peak voltage applied across the x-ray tube indicates differences in the device construction and the object distance from the source. However, these changes do not change the intended device application. The quality of the images obtained from the subject devices were analysed by a radiographer and a radiologist and it was found the images were of good quality which were easily read by the radiologist and hence does not raise the level of safety concern and affect performance. | | Comparable Properties | Subject Device | Predicate Device 1 (K182317) | Predicate Device 2 (K173299) | Comparison Results | | High voltage range | 40 kV–100 kV, 1 kV step | 40-100 kV, 1 kV step | 40-125 kV, 1 kV step | Substantially equivalent X-ray tube voltage setting range is 40kV to maximum peak X-ray voltage, which the tube can handle. Range is a minor element, which can be different but it still maintains the same intended application and hence does not raise the level of safety concern and affect performance. | | mAs range | 0.1 mAs to 250 mAs | 0.4 –100 mAs | 0.1 mAs to 250 mAs | Substantially equivalent Product of X-ray tube current and time is termed as mAs, which is a dependent parameter of power rating and voltage rating which as mentioned above does not change the intended application. APR table recommends the user to use referred value or user can set a value which is appropriate for that examination. It does not raise the level of safety concern and affect performance. | | Comparable Properties | Subject Device | Predicate Device 1 (K182317) | Predicate Device 2 (K173299) | Comparison Results | | Collimator | Manually operated, LED light source, Maximum light field of 48 X 48 cm at 1 m SID, 30 Sec timer. | POSKOM PCMAX- 100CAH: LED lamp, Maximum light field of 47 X 47 cm @ 100 cm SID, 30 Sec timer. | Ralco R72S: Manual, white LED, Single layer square field of 43 X 43 cm at 100 cm SID, 125 kVp. (K030487) | Substantially equivalent Collimator is the device which restricts the X-ray beam within the specified useful area avoiding unintended radiation on the body. Different light field indicates the area of detector that can be used with the system and does | | Comparable Properties | Subject Device | Predicate Device 1 (K182317) | Predicate Device 2 (K173299) | Comparison Results | | Image Receptor | DR | DR | DR…