(55 days)
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.
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.
This document is a 510(k) summary for a portable X-ray machine. It demonstrates substantial equivalence to a predicate device rather than providing acceptance criteria and a study proving the device meets those criteria. Therefore, most of the requested information cannot be extracted directly from the provided text.
However, I can provide the following based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state "acceptance criteria" in terms of specific performance metrics for the device to meet. Instead, it compares the specifications of the subject device to a predicate device to establish substantial equivalence.
Comparison of Subject Device (Heart5R-110, Heart3R-110) vs. Predicate Device (SR-8230/SR-8230S):
| Description | Subject Device (Heart5R-110, Heart3R-110) Performance | Predicate Device (SR-8230/SR-8230S) Performance |
|---|---|---|
| Indications for Use | Acquiring X-ray images of adult anatomy (head, cervical spine, chest, abdomen, lumbar spine, pelvis, extremities). Head, cervical spine, abdomen, lumbar spine, pelvis or extremities when stand-mounted. Chest imaging without a grid when stand-mounted. Not for mammography. | Acquiring X-ray images of adult anatomy (head, cervical spine, chest, abdomen, lumbar spine, pelvis, extremities). Handheld diagnostic imaging of body extremities. Head, cervical spine, abdomen, lumbar spine, pelvis or extremities when stand-mounted. Chest imaging without a grid when stand-mounted. Not 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 | 0.001sec~2sec : R'20 sec Step | 0.02 sec - 6.3 sec: R'10 sec 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 Model | CRUX707i | SIUI SR-8200-39L |
| Collimator Manufacturer | Yian | SIUI |
| Collimator Control | Manual control | Manual with 15, 30, 45, 60sec. Lamp timer |
| 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 | 40~125kV, 86 Step (1kV Step) | 40~125kV, 86 Step (1kV Step) |
| mA Range | 10~100mA, 21 Steps (10,11,12.5,14,16,18,20,22,25,28,32,36,40,45,50,56,63,71,80,90,100mA) | 10~100mA, 11 Steps (10,12.5,16,20,25,32,40,50,64,80,100mA) |
| Exposure Time | 0.001sec~2sec : R'20 sec Step | 0.02~6.3 seconds, 26 Step (in 25% Steps) |
| mAs Range | 0.1~100mAs, 50 Step | 0.4~200mAs, 28 Step (in 25% Steps) |
| X-ray Tube Type | Stationary Anode | Stationary Anode |
| Focal Spot Size (Small/Large) | 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-switch 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 |
| Field Shape (Collimator) | Rectangular | Rectangular |
| Max. Field Size (Collimator) | 43x43cm (at 100cm SID) | 44x44cm (at 100cm SID) |
| Leakage Radiation (Collimator) |
§ 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.