(55 days)
Not Found
No
The document describes a standard portable X-ray machine and does not mention any AI or ML components, image processing capabilities, or performance metrics typically associated with AI/ML algorithms.
No
The device is described as a "Portable X-ray Machine, intended for use by a qualified/trained physician or technician on adult population for the purpose of acquiring X-ray images." Its primary function is diagnostic imaging, not therapeutic treatment.
Yes
The "Intended Use / Indications for Use" section states: "The device may be used for diagnostic imaging of head, cervical spine, abdomen, lumbar spine, pelvis or extremities." This explicitly indicates a diagnostic purpose.
No
The device description explicitly lists hardware components such as a power supply circuit, inverter, high-voltage tank ball tube, filament circuit, control circuit, high-voltage cabinet body, user interface, and collimator, indicating it is a physical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "acquiring X-ray images of the desired parts of patient's anatomy". This is a diagnostic imaging device that works by generating and capturing X-rays, not by analyzing biological samples (like blood, urine, or tissue) in vitro (outside the body).
- Device Description: The description details the components of an X-ray machine, all of which are involved in generating and controlling X-rays for imaging. There is no mention of components or processes related to analyzing biological samples.
- Input Imaging Modality: The input modality is X-ray, which is a form of electromagnetic radiation used for imaging, not for analyzing biological samples.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not perform such analysis.
N/A
Intended Use / Indications for Use
The Heart5R-110. Heart3R-110 are Portable X-ray Machine, intended for use by a qualified/trained physician or technician on adult population for the purpose of acquiring X-ray images of the desired parts of patient's anatomy (including head, cervical spine, chest, abdomen, lumbar spine, pelvis and extremities).
The system is subject to the following limitations of use when stand-mounted:
- The device may be used for diagnostic imaging of head, cervical spine, abdomen, lumbar spine, pelvis or extremities. -The device may be used for imaging of the chest when used without a grid.
This device is not intended for mammography.
Product codes
IZL
Device Description
The Portable X-ray machine directly provides rays for diagnostic operation, which is composed of the following parts: power supply circuit, inverter, high-voltage tank ball tube, filament circuit, control circuit, high-voltage cabinet body, user interface and collimator.
| Model | Heart 5R-110 | Heart 3R-110 |
|---|---|---|
| Power | 5KW | 3KW |
| KV range | 40 to 125 kV | |
| KV precision | $\leq \pm 8%$ | |
| mA range | 10mA to 100mA | 10mA to 71mA |
| mA precision | $\leq \pm 20%$ | |
| ms range | 1~2000ms | |
| ms precision | $\leq \pm (10%+1ms)$ | |
| mAs range | 0.1mAs to 100mAs | |
| mAs precision | $\leq \pm (10%+0.2mAs)$ | |
| Nominal focus size | 0.6/1.8 | |
| The anode target Angle | 15° | |
| Tube core inherently filtered | 0.65mmAL/75KV |
The differences between the Heart 5R and Heart 3R models:
The software is Moderate level of concern, it is original software, and it is not a software for image analysis.
Any x-ray detectors (necessary for a fully-functional x-ray system) are not part of the current submission.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
head, cervical spine, chest, abdomen, lumbar spine, pelvis and extremities
Indicated Patient Age Range
adult population
Intended User / Care Setting
qualified/trained physician or technician
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
The subject of this premarket submission, did not require clinical studies to support substantial equivalence.
Summary of Non-Clinical Tests:
Electrical Safety and Electromagnetic Compatibility Summary
The electrical safety and EMC data included in the submission is in compliance with the following FDA recognized standards:
- ANSI/AAMI ES:60601-1:2005/A2:2010
- ·IEC 60601-1-3 Edition 2.1 2013-04
- •IEC 60601-2-28:2017, Part 2-28
- IEC 60601-2-54:2018, Part 2-54
- •IEC 60601-1-2:2014
Bench Testing Summary
The verification test results showed compliance with the above standards. Validation was performed for overall operation by taking and reviewing test images. The non-clinical tests demonstrate that the device is as safe, as effective, and performs as well as the primary predicate.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1720 Mobile x-ray system.
(a)
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.(b)
Classification. Class II.
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May 4, 2022
Yian Medical Technology (Haining) Co., Ltd Zhiqin Yu RA Supervisor 1st Floor Area 1, 2nd Floor Area 1, Building A, No. 2 Caohejing Road, Haining Economic Development Zone Jiaxing, Zhejiang CHINA
Re: K220700
Trade/Device Name: Heart5R-110 Portable X-Ray Machine, Heart3R-110 Portable X-ray Machine Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: Class II Product Code: IZL Dated: February 28, 2022 Received: March 10, 2022
Dear Zhigin Yu:
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
1
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 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 medical devices and radiation-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, Ph.D. Assistant Director Diagnostic X-ray Systems Team DHT 8B: Division of Radiological Imaging 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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Section 4: Indications for Use Statement (FDA form 3881)
Heart5R-110, Heart3R-110 Portable X-ray Machine
3
Indications for Use
510(k) Number (if known) K220700
Device Name Heart5R-110 Portable X-ray Machine Heart3R-110 Portable X-ray Machine
Indications for Use (Describe)
The Heart5R-110. Heart3R-110 are Portable X-ray Machine, intended for use by a qualified/trained physician or technician on adult population for the purpose of acquiring X-ray images of the desired parts of patient's anatomy (including head, cervical spine, chest, abdomen, lumbar spine, pelvis and extremities).
The system is subject to the following limitations of use when stand-mounted:
- The device may be used for diagnostic imaging of head, cervical spine, abdomen, lumbar spine, pelvis or extremities. -The device may be used for imaging of the chest when used without a grid.
This device is not intended for mammography.
Type of Use (Select one or both, as applicable)
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.
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Section 5: 510(k) Summary
Heart5R-110, Heart3R-110 Portable X-ray Machine
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510(k) Summary (K220700)
| Date Prepared: | Feb 28, 2022 |
|---|---|
| Manufacturer: | Yian Medical Technology (Haining) Co., Ltd |
| 1st Floor Area 1, 2nd Floor Area 1, Building A, | |
| No. 2 Caohejing Road, Haining Economic | |
| Development Zone, Haichang Street, Haining | |
| City, Jiaxing City, Zhejiang Province, China |
Contact Person: Zhiqin Yu RA Supervisor Yian Medical Technology (Haining) Co., Ltd Tel: +86-0573-87217250 zhiqin.yu@yian-medical.com
ldentification of the Device:
| Proprietary/Trade Name: | Heart 5R-110 Portable X-Ray Machine
Heart 3R-110 Portable X-Ray Machine |
|-------------------------|----------------------------------------------------------------------------|
| Classification Name: | Mobile x-ray system |
| Regulatory Number: | 21 CFR Part 892.1720 |
| Product Code: | IZL |
| Device Class: | Class II |
| Review Panel: | Radiology |
Identification of the Legally Marketed Predicate Device:
| Trade Name: | SR-8230 Portable X-ray Unit |
|---|---|
| SR-8230S Portable X-ray Unit | |
| Classification Name: | Mobile x-ray system |
| Regulatory Number: | 21 CFR Part 892.1720 |
| Product Code: | IZL |
| Device Class: | Class II |
| Review Panel: | Radiology |
| Submitter/510(k) Holder: | Shantou Institute of Ultrasonic Instruments Co. |
| Ltd. (SIUI). | |
| Clearance: | K200976 (cleared June 10, 2020) |
Device Description:
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The Portable X-ray machine directly provides rays for diagnostic operation, which is composed of the following parts: power supply circuit, inverter, high-voltage tank ball tube, filament circuit, control circuit, high-voltage cabinet body, user interface and collimator.
| Model | Heart 5R-110 | Heart 3R-110 |
|---|---|---|
| Power | 5KW | 3KW |
| KV range | 40 to 125 kV | |
| KV precision | $\leq \pm 8%$ | |
| mA range | 10mA to 100mA | 10mA to 71mA |
| mA precision | $\leq \pm 20%$ | |
| ms range | 1~2000ms | |
| ms precision | $\leq \pm (10%+1ms)$ | |
| mAs range | 0.1mAs to 100mAs | |
| mAs precision | $\leq \pm (10%+0.2mAs)$ | |
| Nominal focus size | 0.6/1.8 | |
| The anode target Angle | 15° | |
| Tube core inherently | ||
| filtered | 0.65mmAL/75KV |
The differences between the Heart 5R and Heart 3R models:
The software is Moderate level of concern, it is original software, and it is not a software for image analysis.
Any x-ray detectors (necessary for a fully-functional x-ray system) are not part of the current submission.
Indications for Use:
The Heart5R-110, Heart3R-110 are Portable X-ray Machine, intended for use by a qualified/trained physician or technician on adult population for the purpose of acquiring X-ray images of the desired parts of patient's anatomy (including head, cervical spine, chest, abdomen, lumbar spine, pelvis and extremities).
The system is subject to the following limitations of use when stand-mounted:
- The device may be used for diagnostic imaging of head, cervical spine, abdomen, lumbar spine, pelvis or extremities.
-The device may be used for imaging of the chest when used without a grid. This device is not intended for mammography.
Standards:
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- ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A A2:2010/(R)2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD)
-
IEC 60601-1-2 Edition 4.0 2014-02Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance -Collateral Standard: Electromagnetic disturbances - Requirements and tests
- IEC 60601-1-3 Edition 2.1 2013-04 Medical electrical equipment Part 1-3: > General requirements for basic safety and essential performance -Collateral Standard: Radiation protection in diagnostic X-ray equipment
-
IEC 60601-1-6 Edition 3.1 2013-10Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance -Collateral standard: Usability
- IEC 60601-2-28 Edition 3.0 2017-06 Medical electrical equipment Part A 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis
- IEC 60601-2-54 Edition 1.2 2018-06 CONSOLIDATED VERSION Medical A electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy
- ISTA 3B 2017 Packaged-Products for Less-Than-Truckload (LTL) A Shipment
-
IEC 62366-1 Edition 1.0 2015-02 Medical devices - Part 1: Application of usability engineering to medical devices [Including CORRIGENDUM 1 (2016)]
- IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION > Medical device software - Software life cycle processes
-
ISO 15223-1 Fourth edition 2021-07 Medical devices - Symbols to be used with medical device labels, labelling, and information to be supplied - Part 1: General requirements
-
ISO 14971 Third Edition 2019-12 Medical devices - Application of risk management to medical devices
-
ISO 20417:2021 - Medical devices-Information to be supplied by the manufacturer
-
FCC Part 15 Radio Frequency Devices of Part 15B and Part 15C
FDA Guidance Documents:
- "Format for Traditional and Abbreviated 510(k)s Guidance" issued on A September 13, 2019.
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- Radio Frequency Wireless Technology in Medical Devices A
- Guidance for Medical X-ray Imaging Devices Conformance with IEC > Standards
Performance standard:
- 21CFR PART 1010 PERFORMANCE STANDARDS FOR ELECTRONIC A PRODUCTS: GENERAL
- A 21 CFR 1020.30: Diagnostic x-ray system and their major components
- A 21 CFR 1020.31: Radiographic Equipment
Comparison with Predicate Device:
The Heart5R-110, Heart3R-110 Portable X-ray Machine and its predicate device, have the equivalent intended use, functions and similar physical characteristics, performance characteristics.
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Substantial Equivalence:
The comparison between the overall specifications of predicate device (SR-8230/SR-8230S) and the new device (Heart5R-110, Heart3R-110) is shown in Table 1, and the comparison between the Collimator specifications of reference device (SR-8230/SR-8230S) and the new device (Heart5R-110, Heart3R-110) is shown in Table 2. Any differences between the predicate and the new device have no impact on safety or efficacy of the new device and do not raise any new potential or increased safety risks, and the new device is equivalent in performance to existing legally marketed devices.:
| Description | Subject Device | Predicate Device |
|---|---|---|
| Heart5R-110, | ||
| Heart3R-110 | SR-8230/SR-8230S (K200976) | |
| Indications | ||
| for | ||
| use | The Heart5R-110, | |
| Heart3R-110 are Portable | ||
| X-ray Machine, intended for | ||
| use by a qualified/trained | ||
| physician or technician on | ||
| adult population for the | ||
| purpose of acquiring X-ray | ||
| images of the desired parts of | ||
| patient's anatomy (including | ||
| head, cervical spine, chest, | ||
| abdomen, lumbar spine, pelvis | ||
| and extremities). | ||
| The system is subject to the | ||
| following limitations of use | ||
| when stand-mounted: |
- The device may be used for
diagnostic imaging of head,
cervical spine, abdomen,
lumbar spine, pelvis or
extremities.
-The device may be used for
imaging of the chest when
used without a grid. | The SR-8230/SR-8230S
Portable X-ray Unit is a
portable X-ray device, intended
for use by a qualified/trained
physician or technician for the
purpose of acquiring X-ray
images of the desired parts of
patient's anatomy (including
head, cervical spine, chest,
abdomen, lumbar spine, pelvis
and extremities).
The device may be used for
handheld diagnostic
imaging of body extremities.
The system is subject to the
following limitations of use
when stand-mounted: - The device may be used for
diagnostic imaging of head,
cervical spine, abdomen,
lumbar spine,
pelvis or extremities.
-The device may be used for
imaging of the chest when
used without a grid. This device
is not intended |
| Description | Subject Device | Predicate Device |
| | Heart5R-110,
Heart3R-110 | SR-8230/SR-8230S (K200976) |
| | This device is not intended for
mammography. | for mammography. |
| Weight | 17.6kg(Including Collimator) | 15kgs(33.06lb) (Including
Collimator) |
| Size | 367mm×251mm×228mm | 460mm×245mm×188mm |
| Use
Interface | Soft touch
push buttons | SR-8230: Soft touch
push buttons
SR-8230S: Touch screen |
| Exposure
time | 0.001sec2sec : R'20 sec Step | 0.02 sec - 6.3 sec: R'10 sec125kV,86 Step (1kV
Step |
| Memory
Settings
(technique) | 14 memories | 16 memories |
| HF
Generator | High Frequency | High Frequency |
| kW | 5.0KW(Heart5R-110)
3.0KW(Heart3R-110) | 5.0kW |
| kVp | 40-125kVp | 40-125kVp |
| mA | 10mA-100mA (Heart5R-110),
10mA-71mA (Heart3R-110):
R'20 sec Step | 10mA-100mA: R'10 sec Step |
| FDA
Performance
Standard | Complies | Complies |
| Collimator | CRUX707i | SIUI SR-8200-39L |
| Output
Rating | Max. 5.0kW(50mA@100kV) | Max. 5.0kW(40mA@125kV) |
| Type | Microprocessor controlled
High Frequency inverter | Microprocessor controlled
High Frequency inverter |
| kV Range | 40
Step) | 40125kV,86 Step (1kV100mA,21 Steps
Step) |
| mA Range | 10
(10,11,12.5,14,16,18,20,22,25,
28,32,36,40,45,50,56,63,71,80
,90,100mA) | 10100mA, 11 Steps2sec : R'20 sec Step | 0.02
(10,12.5,16,20,25,32,40,50,64,
80,100mA) |
| Exposure | 0.001sec6.3 seconds |100mAs, | 0.4~200mAs, |
| Description | Subject Device
Heart5R-110,
Heart3R-110 | Predicate Device
SR-8230/SR-8230S (K200976) |
| Time | | 26 Step (in 25% Steps) |
| mAs | 0.1
| Range | 50 Step | 28 Step ( in 25% Steps) |
| X-ray Tube
Type | Stationary Anode | Stationary Anode |
| Focal Spot
Size
(Small/Larg
e) | 0.6/1.8mm | 0.6/1.8mm |
| Anode
Heat
Storage
Capacity | 42,000HU | 42,000HU (30,000J) |
| Power
Cord
Length | 2.08m | 3m |
| Exposure
Hand-switc
h Cord
Length | 5m | 6m (Max. Length) |
| X-ray
switching
frequency | 60KHZ | 100kHz |
| Control | 2 Point Control (kV, mAs) | 2 Point Control (kV, mAs) |
| Anatomical
Programs | Preprogrammed 16 APR data-
User Programmable | Preprogrammed 16 APR data-
User Programmable |
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Table 2 Collimator Specs Comparison
| Description | Subject Device | Predicate Device |
|---|---|---|
| Heart5R-110, | ||
| Heart3R-110 | SR-8230/SR-8230S | |
| (K200976) | ||
| Model | CRUX707i | SR-8200-39L |
| Manufacturer | Yian | SIUI |
| Control | Manual control | Manual with 15, 30, 45, |
| 60sec. Lamp timer |
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| Field Shape | Rectangular | Rectangular |
|---|---|---|
| Max. Field Size | 43x43cm (at 100cm SID) | 44x44cm (at 100cm SID) |
| Leakage Radiation |