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510(k) Data Aggregation
(73 days)
The AllTest Urinary Tract Infection Test is for the qualitative detection of Leukocytes (white blood cells) and nitrite in urine as an aid in the screening of a Urinary Tract infection (UTI). It is intended for over-the-counter home use only.
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(219 days)
The Huxley Home Sleep Apnea Test (SANSA) is a wearable device intended for use in the recording, analysis, and storage of biophysical parameters to aid in the evaluation of sleep-related breathing and cardiac disorders of adults suspected of sleep apnea. The device is intended for the clinical and home use setting under the direction of a Healthcare Professional (HCP). The system is prescription use only.
The SANSA device records and stores ECG recording for up to 10 hours of wear time which can be displayed in the software portal for manual annotation and analysis. The SANSA does not provide automated analysis of the ECG and is not intended to be used with a 3rd party automated algorithm and is not intended for pacemaker analysis.
The Huxley Home Sleep Apnea Test (SANSA™) is a wearable device intended for use in the recording, analysis, and storage of biophysical parameters to aid in the evaluation of sleep-related breathing disorders of adults suspected of sleep apnea. The device is intended for clinical and home use setting under the direction of a Healthcare Professional (HCP). The system is prescription use only. The SANSA™ device records and stores ECG recording for up to 10 hours of wear time which can be displayed in the software portal for manual annotation and analysis. The SANSA™ does not provide automated analysis of the ECG and is not intended to be used with a 3rd party automated algorithm and is not intended for pacemaker analysis.
The SANSA HSAT collects multiple physiological signals using a single wearable patch worn on the chest. The SANSA device contains a reflective PPG sensor, a single-lead ECG sensor, and a 3-axis accelerometer. The signals from these sensors are passed into a cloud-based algorithm which utilizes a combination of signal processing and AI/ML components to compute time-series data for clinician review and summary metrics for report output. The device outputs the following time-series channels: Oximetry, Heart Rate, Chest Movement, Snoring, Body Position, Respiratory Effort, Actigraphy, Sleep staging (Sleep/Wake), and ECG. The following summary metrics are calculated: sansa-Apnea Hypopnea Index (sAHI) and Total Sleep Time (TST).
Recorded data are uploaded to a software portal where physiological tracings are made available for review and event editing by a qualified healthcare professional. The device is intended to be worn for 10 hours per study.
Here's a breakdown of the acceptance criteria and the study information for the SANSA HSAT device, based on the provided FDA 510(k) clearance letter:
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria and performance data are primarily found on Page 9 of the document, under the "Performance" section within "Table 1: Device Comparison."
| Performance Metric | Acceptance Criteria / Predicate Performance (K202359) | Reported Device Performance (SANSA HSAT) | Comparison |
|---|---|---|---|
| Heart Rate (Arms) | No Heart Rate Analysis (Predicate) | ≤ 3 bpm (range 30-250 bpm) | N/A |
| SpO2 (Arms) | Does not collect SpO2 (Predicate) | ≤ 3% (range 70-100%) | N/A |
| Aid to Diagnosis of Moderate to Severe OSA (AHI≥15) - Sensitivity | Not applicable (Predicate does not diagnose OSA) | 88.2% | N/A |
| Aid to Diagnosis of Moderate to Severe OSA (AHI≥15) - Specificity | Not applicable (Predicate does not diagnose OSA) | 87.3% | N/A |
| ECG Recording Accuracy: Frequency Response | 0.67 Hz to 40 Hz | 0.67 Hz to 40 Hz | Identical |
| ECG Recording Accuracy: Input Impedance | >10 MΩ | >10 MΩ | Identical |
| ECG Recording Accuracy: Gain Accuracy | Maximum amplitude error ±10% | Maximum amplitude error ±10% | Identical |
| ECG Recording Accuracy: Gain Stability | <3% over a 24-hour period | <3% over a 24-hour period | Identical |
| ECG Recording Accuracy: Timing Accuracy | <30 seconds | <30 seconds | Identical |
Note: For Heart Rate, SpO2, and OSA diagnosis metrics, the predicate device (iRhythm Zio Monitor) does not provide these analyses or collect SpO2. Therefore, the "acceptance criteria" for these aspects are implicitly met by the absence of safety/effectiveness concerns with the SANSA HSAT's reported performance, which aligns with its intended use in sleep apnea evaluation. The ECG recording accuracy metrics are directly comparable and are identical between the subject device and the predicate.
2. Sample Size and Data Provenance for the Test Set
The document does not explicitly state the sample size used for the clinical performance validation of the SANSA HSAT's ECG, nor does it specify the country of origin or whether the data was retrospective or prospective. It only mentions:
- Sample Size: Not specified.
- Data Provenance: Not specified (country/retrospective/prospective).
For the Aid to Diagnosis of OSA, a sensitivity of 88.2% and specificity of 87.3% are reported. The document does not provide the sample size or provenance for this particular study, but it was leveraged from a previous clearance (K244027).
3. Number of Experts and Qualifications for Ground Truth - Test Set
The document does not provide details on the number or qualifications of experts used to establish ground truth for the test set specifically for the ECG clinical performance validation.
For the "Aid to Diagnosis of Moderate to Severe OSA", the percentages suggest a comparison against a diagnostic standard, which would typically involve expert interpretation, but the details are not provided in this document.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method (e.g., 2+1, 3+1) used for establishing the ground truth for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No information is provided about a multi-reader multi-case (MRMC) comparative effectiveness study, or any effect size related to human reader improvement with or without AI assistance. The SANSA device explicitly states it "does not provide automated analysis of the ECG and is not intended to be used with a 3rd party automated algorithm." (Pages 4 and 5).
6. Standalone Performance Study
Yes, a standalone performance study was done for the SANSA HSAT's ECG:
- Study Type: "Sansa ECG clinical performance was validated through comparison to a simultaneously collected reference standard Holter monitor." (Page 11)
- Performance: "Clinically acceptable performance was demonstrated through qualitative and quantitative analysis of the ECG signal." (Page 11)
The reported sensitivity and specificity for OSA diagnosis (Page 9) also represent standalone algorithm performance.
7. Type of Ground Truth Used
- For ECG Clinical Performance: "simultaneously collected reference standard Holter monitor." (Page 11)
- For Aid to Diagnosis of OSA (reported sensitivity/specificity): While not explicitly stated, the context of "Aid to Diagnosis" for Sleep Apnea typically implies comparison to a polysomnography (PSG) study, which is the gold standard, interpreted by sleep specialists. This data was "leveraged from previous clearance."
8. Sample Size for the Training Set
The document does not provide any information about the sample size used for a training set. This is consistent with the statement that the device does not provide automated analysis of the ECG and explicitly states that it is not intended for use with a 3rd party automated algorithm. While the device uses "AI/ML components" for other signals (Snoring, Body Position, Respiratory Effort, Actigraphy, Sleep staging), the training set size for these components is not detailed in this document.
9. How Ground Truth for the Training Set Was Established
The document does not provide information on how the ground truth for any potential training set was established. Given the focus on manual annotation and analysis for ECG, and the lack of detail on the AI/ML components for other signals, this information is not present in the clearance letter.
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(116 days)
General Total Knee Arthroplasty (TKR) Indications:
- Painful, disabling joint disease of the knee resulting from: noninflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis, or avascular necrosis), rheumatoid arthritis or post-traumatic arthritis.
- Post-traumatic loss of knee joint configuration and function.
- Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability.
- Revision of previous unsuccessful knee replacement or other procedure.
- Fracture of the distal femur and/or proximal tibia that cannot be stabilized by standard fracture-management techniques
The Triathlon® Gold Femoral Components are indicated for both uncemented and cemented use.
The Triathlon® Total Knee System is a total knee prosthesis designed to resurface the articulating surface of the femoral and tibial bones. In a total knee replacement, Triathlon® Gold Femoral Components are intended to replace the articulating surface of the distal femur and articulate against an articular surface of the tibial component as well as an optional patellar component. Triathlon® Gold Femoral Components are additively manufactured from Ti-6Al-4V powder, using Electron Beam Melting (EBM) technology, and then fully coated with titanium nitride (TiN), using Physical Vapor Deposition (PVD). In addition to TiN coating, the bone cut facing surfaces of these femoral components contain the Tritanium® porous structure. Indicated for both uncemented and cemented use, the subject femoral components are provided in right and left configurations and eight proportional sizes (sizes 1-8) for a total of 16 unique components to accommodate differences in patient anatomy. The subject femoral components are sterile, single use devices.
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(216 days)
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid (Black) is a non-sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. It is also tested to be used against Chemotherapy Drugs and Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid. The gloves were tested for use with chemotherapy drugs and fentanyl citrate as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
| Chemotherapy Drug | Concentration | Minimum Breakthrough Detection Time in Minutes |
|---|---|---|
| Azacytidine | (25.0 mg/ml) | >240 |
| Carmustine | (3.3 mg/ml) | 25.0 |
| Cisplatin | (1.0 mg/ml) | >240 |
| Cyclophosphamide | (20.0 mg/ml) | >240 |
| Carboplatin | (10.0 mg/ml) | >240 |
| Dacarbazine | (10.0 mg/ml) | >240 |
| Docetaxel | (10.0 mg/ml) | >240 |
| Doxorubicin HCl | (2.0 mg/ml) | >240 |
| Epirubicin | (2.0 mg/ml) | >240 |
| Etoposide | (20.0 mg/ml) | >240 |
| Fluorouracil | (50.0 mg/ml) | >240 |
| Gemcitabine | (38.0 mg/ml) | >240 |
| Ifosfamide | (50 mg/ml) | >240 |
| Irinotecan | (20.0 mg/ml) | >240 |
| Methotrexate | (25.0 mg/ml) | >240 |
| Mitomycin C | (0.5 mg/ml) | >240 |
| Mitoxantrone | (2.0 mg/ml) | >240 |
| Oncovin | (1.0mg/ml) | >240 |
| Oxaliplatin | (5.0 mg/ml) | >240 |
| Paclitaxel | (6.0 mg/ml) | >240 |
| Thiotepa | (10.0 mg/ml) | 55.7 |
| Vinorelbine | (10.0 mg/ml) | >240 |
| Vincristine Sulfate | (1.0 mg/ml) | >240 |
Testing showed a minimum breakthrough time of 25.0 minutes with Carmustine and 55.7 minutes with Thiotepa
Warning: Do not use with Carmustine
| Fentanyl Citrate | Concentration | Minimum Breakthrough Detection Time in Minutes |
|---|---|---|
| Fentanyl Citrate Injection | 100 mcg/2ml | >240 |
| Fentanyl Citrate mixed with Simulated Gastric Acid at a 50:50 ratio | >240 |
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid (Black) is a disposable single-use, non-sterile, Black and powder-free ambidextrous glove made from nitrile butadiene rubber.
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(107 days)
The TunnelVision Endoscopic Soft Tissue Release System is indicated for use in minimally invasive ligament or fascia release:
- Carpal tunnel release in the wrist
- Cubital tunnel release in the elbow
The HBL Blade Assembly is indicated for use with the TunnelVision Endoscopic Soft Tissue Release System, the 3M Agee Inside Job Carpal Tunnel Release System, or the MicroAire SmartRelease Endoscopic Soft Tissue Release System in minimally invasive ligament or fascia release:
- Carpal tunnel release in the wrist
- Cubital tunnel release in the elbow
Hand Biomechanics Lab's TunnelVision Endoscopic Soft Tissue Release System is a surgical system designed for minimally invasive soft tissue release procedures. The system includes the TunnelVision Endoscope, TunnelVision Handpiece, reusable manual surgical instruments (small and medium dilators, synovium elevator, coequal dilator), an instrument sterilization tray, and the HBL Blade Assembly.
The HBL Blade Assembly (Model CTR-455) was previously cleared under 510(k) K222490 for use with the 3M® and MicroAire® SmartRelease® systems. This submission expands indications for use to include compatibility with the TunnelVision platform. No changes were made to blade assembly materials, design, or sterilization method.
Reusable components (handpiece, endoscope, surgical instruments, sterilization tray) are supplied non-sterile, to be cleaned and steam sterilized by the end user. The HBL Blade Assembly is a sterile, gamma-irradiated, single-use device.
The subject device is comprised of two components:
- TunnelVision Endoscopic Soft Tissue Release System – includes the endoscope, handpiece, manual surgical instruments, and sterilization tray. These components are reusable following validated cleaning and sterilization processes.
- HBL Blade Assembly – a gamma-sterilized, single-use disposable device containing the cutting blade. The blade cuts in a retrograde direction to safely release the targeted soft tissue.
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(219 days)
SleeveLUX Anoscope/Proctoscope is a class 2 self-illuminating disposable instrument used to assist clinicians when treating and/or diagnose conditions in the anal canal and the lower rectum such as 1st 2nd and 3rd degree hemorrhoids.
The SleeveLUX Anoscope/Proctoscopes (PS24000001) are class 2 self-illuminating, single use, disposable instrument (medical device) used to assist clinicians treat and/or diagnose conditions in the anal canal and the lower rectum such as 1st 2nd and 3rd degree hemorrhoids. The SleeveLUX Anoscope/Proctoscopes must only be used by trained professionals. The SleeveLUX Anoscope/Proctoscope is not manufactured using tissues of animal origin, does not contain human blood derivatives or medicinal products.
The SleeveLUX Anoscope/Proctoscope is a plastic self-illuminating disposable instrument comprised of five main components:
- Main body tube
- Sleeve
- Trocar
- Handle
- LED module
The SleeveLUX is used for diagnosing and treating conditions in the lower rectum and anal canal. The trocar and sleeve are introduced to position the sleeve in the anus. After the trocar is removed, the main body tube is then inserted into the anus along with the locking system on the sleeve and main body tube. The LED module can then be switched on. The SleeveLUX can then freely move within the sleeve with no discomfort to the patient eliminating the need for multiple introductions. The locking system also helps prevent withdrawing a biopsy or treating hemorrhoids distal to the dentate line.
Proctoscopy is a common procedure performed to examine the anal canal and rectum for conditions such as anal fissures haemorrhoids, carcinoma, inflammation, internal bleeding, tumours and polyps. A proctoscope is a very general and novel tool that can also be used therapeutically in conduction with other instruments such as band ligators, forceps catheters and other general surgical equipment for the treatment of haemorrhoids, polypectomy and to take biopsies.
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(119 days)
The wrist automatic blood pressure monitor LD-735,LD-752,LD-753 is intended for the non-invasive measurement of systolic and diastolic arterial blood pressure and pulse rate in adults (aged 15 and above).
The Wrist Automatic Blood Pressure Monitor is an automatic, non-invasive, blood pressure measurement device that is intended to measure the systolic and diastolic arterial blood pressure and pulse rate. The systolic and diastolic pressure are determined using the oscillometric method, where the cuff is inflated with a pump and deflates via an automatic electronic valve. During the inflation measurements, an electric pump within the main unit slowly inflates the wrist cuff, generating cuff pressure which is monitored and from which pulse waveform data is extracted. This waveform data is analyzed by software algorithms within the sensor to determine systolic pressure and diastolic pressure.
The Wrist Automatic Blood Pressure Monitor consists of two parts: main unit and the wrist cuff. The main unit is mainly composed of pump, valve, PCB, enclosure and LCD. The cuff, which is applicable to wrist circumference approximately between 12.5 and 20.5cm, includes the inflatable bladder and the nylon shell.
This device adopts the oscillometric technology with Fuzzy Algorithm to measure the arterial blood pressure and pulse rate. The cuff is wrapped around the arm and automatically inflated by the air pump. The sensor of the device catches weak fluctuation of the pressure in the cuff produced by extension and contraction of the artery of the arm in response to each heartbeat. The amplitude of the pressure waves is measured, converted in millimeters of the mercury column, and is displayed by digital value.
This FDA 510(k) clearance letter pertains to three models of wrist automatic blood pressure monitors (LD-735, LD-752, LD-753) submitted by HONSUN (Nantong) Co.,Ltd. The clearance is based on the substantial equivalence of these devices to a legally marketed predicate device, the Wrist Automatic Blood Pressure Monitor LD-737 (K131463).
The primary focus of the submission and the FDA's review is on demonstrating that the new devices do not raise new issues of safety or effectiveness compared to the predicate. The document thoroughly compares the technical characteristics and functions of the subject devices to the predicate.
Here's an analysis of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" as a separate, quantitative set of thresholds for clinical performance that the device must meet in a specific study. Instead, the "acceptance criteria" appear to be implicit in the compliance with recognized standards and the declared measuring accuracy specification. The study performed is a non-clinical bench testing comparison to the predicate device and compliance with relevant safety and performance standards.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Measuring Accuracy (Static Pressure): $\pm$3mmHg (based on predicate device spec) | $\pm$3mmHg for static pressure (Subject devices claim same specification, implying they meet this through compliance with ISO 80601-2-30) |
| Measuring Accuracy (Pulse Rate): $\pm$5% of the reading (based on predicate device spec) | $\pm$5% of the reading for the pulse rate (Subject devices claim same specification, implying they meet this through compliance with ISO 80601-2-30) |
| Biocompatibility: Compliance with ISO 10993-5 and ISO 10993-10 | All user-directly contacting materials are compliant with ISO 10993-5 and ISO 10993-10 requirements (claimed to be same materials as predicate) |
| Electrical Safety: Compliance with ANSI AAMI ES 60601-1 | Complies with ANSI AAMI ES 60601-1 |
| Electromagnetic Compatibility (EMC): Compliance with IEC 60601-1-2 | Complies with IEC 60601-1-2 |
| Home Healthcare Environment: Compliance with IEC 60601-1-11 | Complies with IEC 60601-1-11 |
| Automated Non-Invasive Sphygmomanometers: Compliance with ISO 80601-2-30 | Implied compliance through similar specifications and general statement of performance. The standard itself outlines the performance requirements for such devices. |
| Software Verification & Validation: Compliance with FDA guidance | Performed in accordance with "Guidance for the Content of Premarket Submissions for Software Contained In Medical Devices" |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states that "bench testing" was conducted. However, it does not provide any details on the sample size used for this testing or the specific data provenance (e.g., country of origin, retrospective/prospective). The testing mentioned is primarily related to compliance with various electrical, EMC, and environmental standards, as well as biocompatibility. For measuring accuracy, the statement merely re-iterates the specification as being the same as the predicate, suggesting that this specification was verified during the "bench testing" rather than proven with a new clinical study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not mention any human experts establishing ground truth for the "test set." The evaluation appears to be based on engineering and laboratory testing for compliance with technical standards and comparison to the predicate device's specifications. This is a blood pressure monitor, not an AI/imaging diagnostic device that would typically require expert ground truth labeling.
4. Adjudication Method for the Test Set
Since no human experts were involved in establishing ground truth for a test set in the traditional sense (e.g., for diagnostic accuracy), there was no adjudication method described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
No MRMC comparative effectiveness study was done or is applicable to this device. This is a standalone medical device (blood pressure monitor), not an AI-based diagnostic tool intended to assist human readers or clinicians.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The document outlines an assessment of non-clinical testing which included electrical safety, EMC, biocompatibility, and software verification/validation. The device itself is an "automatic blood pressure monitor," meaning its core function is to autonomously measure blood pressure. Therefore, the "bench testing" and compliance with standards like ISO 80601-2-30 (Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers) serve as the standalone performance evaluation for the device's accuracy and safety, without human intervention in the measurement process itself. The document states: "The performance tests demonstrate that the wrist automatic blood pressure monitor performs comparably to the predicate device that is currently marketed for the same intended use." This indicates a standalone performance assessment against established benchmarks (the predicate and relevant standards).
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
For the primary function of blood pressure measurement accuracy, the ground truth is implicitly defined by the measurement standards provided in ISO 80601-2-30, which typically refers to reference measurements from a calibrated clinical-grade sphygmomanometer (e.g., mercury sphygmomanometer). For other aspects, the ground truth for compliance is the relevant international and national standards (e.g., ISO 10993 for biocompatibility, IEC 60601 series for electrical safety and EMC).
8. The Sample Size for the Training Set
Not applicable/Not mentioned. This device is a hardware-based blood pressure monitor using an "oscillometric method with Fuzzy Algorithm." While a "Fuzzy Algorithm" implies some form of computational processing, the document does not indicate that it is a machine learning or AI algorithm that requires a "training set" in the modern sense of deep learning or complex predictive modeling. The algorithm is a fixed part of the device's operation.
9. How the Ground Truth for the Training Set Was Established
Not applicable/Not mentioned for the same reasons as #8. If the "Fuzzy Algorithm" involved a "training" or calibration phase during its development, the details are not provided in this regulatory document.
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(143 days)
This intermittent catheter is a flexible tubular device that is inserted through the urethra by male, female and pediatric patients who need to drain urine from the bladder.
Note: 8 inch Sleeved IC 3 Pocket consists of a subset of the original population:
8 inch Sleeved IC 3 Pocket
This intermittent catheter is a flexible tubular device that is inserted through the urethra by female and female paediatric (pediatric) patients who need to drain urine from the bladder.
Sleeved IC 3 (not finalized) catheters are E-beam sterilized hydrophilic-coated, single-use catheters. The subject device has two drainage eyelets that are used to manage urinary incontinence.
The device is inserted into the urethra to drain urine from the bladder.
The device is available in 16 inch and 8-inch lengths. The device is available in various Fr sizes ranging from Fr 08 through Fr 16. The catheter is made from Thermo-plastic Elastomer (TPE), (not made with phthalates, not made with PVC). The catheter sleeve is manufactured from Low Density Polyethylene (LDPE). The catheter sleeve allows for the user to grip the catheter anywhere along the length during insertion.
The device is packaged in a foil which was designed to be easy to open and to facilitate access to the catheter. The device is contained in a primary package that consists of both the catheter assembly and the hydration fluid. This means that the coated catheter surface is lubricated by direct contact with the hydration fluid. The device is available with and without the integrated urine collection bag. The device is available in straight and pocket packaging configurations.
The subject device covers several configurations:
• Sleeved IC 3 straight (SWT) is an intermediate catheter in a straight configuration
• Sleeved IC 3 Plus is the same catheter with an attached urine bag
• Sleeved IC 3 Pocket has the catheter coiled up for a smaller footprint
• Sleeved IC 3 Plus Pocket is the same coiled catheter with an attached urine bag
The devices are surface devices with mucosal membrane contact with prolonged contact duration (> 24 hours to 30 days) due to cumulative use. The devices are intended to be used in both professional healthcare facilities and the home environment.
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(268 days)
HPACS is a web-based software solution intended for storing, retrieving, transmitting, viewing, and processing medical images for non-diagnostic purposes. It operates in conjunction with a PACS server to enable access to imaging data.
HPACS supports the display and comparison of images from CR, CT, DX, MR, US, XA, and SC modalities that are compliant with the DICOM standard.
The system is designed for use by radiologists, technologists, and clinicians for reference and review purposes only. It is not intended for primary diagnostic interpretation.
HPACS supports operation on Windows 10 or higher and macOS 12 or higher platforms, exclusively via Google Chrome browser. Compatibility with other browsers or operating systems is not claimed.
HPACS is not intended for diagnostic image reading and should be used under standard indoor lighting conditions for optimal viewing; use in direct sunlight or high-glare environments is not recommended, and mobile or tablet devices are not supported. HPACS is not supported on any OS that is no longer officially supported by its manufacturer (e.g., Windows 7).
HPACS is a software system that allows healthcare professionals to access and manipulate medical images in real time using any web browser without device/location restrictions, without installing client software. The PACS application program runs on the AWS Cloud server. It stores, searches, and retrieves medical images and meta information using an initialization database based on secure communication, logging, DICOM tags stored in the DB, and file storage information stored in the AWS Cloud. AWS Cloud provides storage, query, and retrieval functions only to authorized users, and blocks unauthorized access. It also provides a web browser-based PACS/Web Viewer UI that can interact with the PACS application program to store and retrieve medical images and meta information.
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(58 days)
The Picosecond Laser device is intended for use in surgical and aesthetic application in the medical dermatology and general and plastic surgery as follows:
1064nm wavelength:
- Removal of tattoos on all skin type (Fitzpatrick skin types I-VI) with the following tattoo colors: black, brown, green, blue and purple.
- Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV.
532nm wavelength:
- Removal of tattoos on Fitzpatrick skin types I-III with the following tattoo colors: red, yellow and orange.
- Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV.
Composition of therapeutic device: main unit, light guide arm, handpiece and foot switch. The main unit includes display screen, laser, power supply, water circulation cooling system and electronic control components. Accessories include goggles, eye mask, standard hand tools, power cord, fuse tube, funnel component, drain faucet, user manual, remote control interlock connector, drain spout and keys.
The Picosecond Laser Device is a multi-wavelength, pulsed laser system designed for the treatment of benign pigmented lesions and removal of tattoos. A key feature of the device is its ability to produce multiple laser wavelengths (1064 nm and 532 nm).
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