(268 days)
No
The summary describes standard image processing, storage, and annotation features, with no mention of AI, ML, or related concepts.
No.
The device is for image processing and management, not for directly treating or diagnosing medical conditions.
Yes
The 'Intended Use / Indications for Use' states, "AspenView is indicated for use in general radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures." This clearly indicates its use in diagnostic procedures.
No
The device description explicitly states that the software is "developed to use Aspen Imaging Flat Panel DR Detector and Aspen Imaging Healthcare Inc Image Viewer." This indicates a dependency on specific hardware components (the detector and viewer), meaning the device is not solely software.
Based on the provided information, AspenView is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- AspenView's Function: AspenView is a software intended for processing, managing, and annotating radiographic images (X-rays) of human anatomy. It works with images acquired from a digital X-ray detector.
- No Biological Samples: The device description and intended use clearly indicate that AspenView operates on medical images, not on biological samples taken from a patient.
Therefore, AspenView falls under the category of medical imaging software, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
AspenView is indicated for use in general radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures (excluding fluoroscopic, angiographic, and mammographic applications). The main features of this software are storing acquired images, data management, image processing and image stitching.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
AspenView software is designed for use by radiologists and radiology technicians for annotation in the X-ray images. The AspenView software is developed to use Aspen Imaging Flat Panel DR Detector and Aspen Imaging Healthcare Inc Image Viewer. The purpose of AspenView software is for the doctor to annotate X-ray images and then to print out with patient information or sent to another PACS system.
A client user needs to install AspenView first in the recommended PC environment. After installation, the client user chooses a DICOM format in the uploaded patient list to be annotated, and then annotation is written by user after reviewing of image chosen. After annotation has completed it can be printed out, saved or sent to another PACS system.
AspenView software includes an image stitching function to read multiple medical images at one time by stitching them to one image based on overlapping areas. It supports DICOM 3.0 which is standard of medical image format as well as Tiff and Raw images. It provides additional functions such as image retrieval, storage, and transmission.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
General radiographic images of human anatomy (X-ray images)
Anatomical Site
Human Anatomy
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Radiologists and radiology technicians
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Safety testing and documentation was performed in accordance with IEEE 1012-2012, Standard for System and Software Verification and Validation. [AspenView-SVsR]
Software information is provided in accordance with FDA guidance: "The content of premarket submissions for software contained in medical devices."
Cybersecurity information is provided in accordance with FDA quidance: "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of that is the FDA logo, which consists of a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font size below that.
Aspen Imaging Healthcare Inc % Dave Kim Regulatory Affairs Consultant Mtech Group LLC 7505 Fannin St. Suite 610 Houston, Texas 77054
February 12, 2025
Re: K241425
Trade/Device Name: AspenView Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: LLZ Dated: January 6, 2025 Received: January 6, 2025
Dear Dave Kim:
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 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/cfpm/pm.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.
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 System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and
1
production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 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-regulatoryinformation/postmarketing-safety-reporting-combination-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 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-device-advice-comprehensive-regulatory-assistance/unique-deviceidentification-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-device-safety/medical-device-reporting-mdr-how-report-medicaldevice-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/deviceadvice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuingeducation/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-deviceadvice-comprehensive-regulatory-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,
Jessica Lamb
Jessica Lamb, PhD Assistant Director, Imaging Software 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
2
Indications for Use
510(k) Number (if known) K241425
Device Name
AspenView
Indications for Use (Describe)
AspenView is indicated for use in general radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures (excluding fluoroscopic, and mammographic applications). The main features of this software are storing acquired images, data management, image processing and image stitching.
| 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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Image /page/3/Picture/1 description: The image shows the logo for Aspen Imaging Healthcare. The logo consists of the letters A and I in a dark blue color, with a dot between them. To the right of the letters, the words "ASPEN IMAGING" are written in a dark blue color, and below that, the word "HEALTHCARE" is written in a light gray color.
1. Traditional 510(k) SUMMARY: K241425
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR Part 807.92.
Date 510K summary prepared : February 7, 2025
Submitter's Name, address, telephone number, a contact person:
| Submitter's Name : | Aspen Imaging Healthcare Inc |
|---|---|
| Submitter's Address: | 801 Jupiter Rd Suite 200, Plano, TX 75074, USA |
| Contact Person: | Mr. Casey Lee, Vice President (casey.lee@aspenimaging.com) |
| Submitter's Telephone: | (+1) 214-257-0113 |
| Contact person: | |
| Official Correspondent: | Dave Kim, MBA (davekim@mtechgroupllc.com) |
| Mtech Group LLC | |
| Address: | 7505 Fannin St. Ste 610, Houston, TX 77054 |
| Telephone: | (+1) 713-467-2607 |
Name of the device, including the trade or proprietary name if applicable, the common or usual name and the classification name, if known:
| Trade/proprietary name: | AspenView |
|---|---|
| Regulation Name: | Medical Image Management And Processing System |
| Regulation Number: | 21 CFR 892.2050 |
| Regulatory Class: | II |
| Product Code: | LLZ |
| Predicate Device | |
| Manufacturer: | DRTECH Corporation |
| Device: | EConsole1 |
| 510(k) Number: | K231225 |
| Classification Name: | Medical Image Management And Processing System |
| Regulatory Number: | 21 CFR 892. 2050 |
| Regulatory Class: | II |
| Product Code: | LLZ |
2. Device Description
AspenView software is designed for use by radiologists and radiology technicians for annotation in the X-ray images. The AspenView software is developed to use Aspen Imaging Flat Panel DR Detector and Aspen Imaging Healthcare Inc Image Viewer. The purpose of AspenView software is for the doctor to annotate X-ray images and then to print out with patient information or sent to another PACS system.
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Image /page/4/Picture/0 description: The image shows the logo for Aspen Imaging Healthcare. The logo consists of a stylized "A.I." in dark blue on the left. To the right of the "A.I." are the words "ASPEN IMAGING" in a dark sans-serif font, with the word "HEALTHCARE" in a lighter gray sans-serif font underneath. The overall design is clean and modern.
A client user needs to install AspenView first in the recommended PC environment. After installation, the client user chooses a DICOM format in the uploaded patient list to be annotated, and then annotation is written by user after reviewing of image chosen. After annotation has completed it can be printed out, saved or sent to another PACS system.
AspenView software includes an image stitching function to read multiple medical images at one time by stitching them to one image based on overlapping areas. It supports DICOM 3.0 which is standard of medical image format as well as Tiff and Raw images. It provides additional functions such as image retrieval, storage, and transmission.
3. Indications for Use
AspenView is indicated for use in general radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures (excluding fluoroscopic, angiographic, and mammographic applications). The main features of this software are storing acquired images, data management, image processing and image stitching.
4. Summary of Design Control Risk management
After the analysis of risk management, there are no more risk factors and no more actions needed either. Risk management, during the life cycle from product planning, design process to follow- up manaqement, identified foreseeable risks in accordance with ISO 14971:2019 (Recog. No: 5-125), IEC 62304:2015 (Recog. No: 13-79) and ISO 13485:2019/AC2016 standards. The validation of risk management was performed by the radiologist who had the experience in clinical field according to the risk management plan.
5. Comparison with predicate device:
AspenView is a medical software that digitizes signals received from the detector and displays x-ray images. Additionally, it allows for the entry of patient information, image capture details, and other necessary references for enhanced convenience. The technological characteristics of AspenView are substantially equivalent to those of Econsole1, the predicate device. Functionally, it mirrors the capabilities of the predicate device. AspenView does not have control over exposure settings, electrical adjustments, or the calibration of the X-ray system. Furthermore, AspenView is validated to interface with the Aspen Imaging detector, IODR1417 (K241346).
| Characteristic | Proposed : AspenView | Predicate Device: EConsole1 | Remark |
|---|---|---|---|
| Manufacturer | Aspen Imaging Healthcare Inc | DRTECH Corporation |
6. Substantial Equivalence
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Image /page/5/Picture/0 description: The image contains the logo for Aspen Imaging Healthcare. The logo consists of a stylized "A.I." on the left, with the words "ASPEN IMAGING" to the right of the letters. Below "ASPEN IMAGING" is the word "HEALTHCARE" in a lighter font.
| 510(k) number | K241425 | K231225 | |
|---|---|---|---|
| Intended Use | AspenView is indicated for use | ||
| in general radiographic images | |||
| of human anatomy. It is | |||
| intended to replace | |||
| radiographic film/screen | |||
| systems in all general-purpose | |||
| diagnostic procedures | |||
| (excluding fluoroscopic, | |||
| angiographic, and | |||
| mammographic applications). | |||
| The main features of this | |||
| software are storing acquired | |||
| images, data management, | |||
| image processing and image | |||
| stitching. | EConsole1 is indicated for use | ||
| in general radiographic images | |||
| of human anatomy. It is | |||
| intended to replace | |||
| radiographic film/screen | |||
| systems in all general-purpose | |||
| diagnostic procedures | |||
| (excluding fluoroscopic, | |||
| angiographic, and | |||
| mammographic applications). | |||
| The main features of this | |||
| software are controlling and | |||
| interfacing the detector, | |||
| controlling the x-ray generator | |||
| acquisition settings, storing | |||
| acquired images, data | |||
| management and image | |||
| processing | Same | ||
| Regulation | |||
| Number | 21 CFR 892.2050 | 21 CFR 892.2050 | Same |
| Operating | |||
| System | |||
| Requirement | Windows 10 and Windows based | ||
| operating system | Windows 7 or | ||
| Windows 8 or | |||
| Windows 10 | Similarity | ||
| Acquisition | |||
| devices | Digital X-ray Detector | Digital X-ray Detector | Same |
| Software | |||
| Function | Image viewing | ||
| Image search | |||
| Image storage | |||
| Image annotation | |||
| Image measurement | |||
| Image processing | |||
| Image stitch | Image viewing | ||
| Image search | |||
| Image storage | |||
| Image annotation | |||
| Image measurement | |||
| Image processing | |||
| Image stitch | |||
| Generator Control | Same | ||
| DICOM | |||
| Compliance | Yes | Yes | Same |
There are no significant differences between AspenView and the predicate device that would adversely affect the use of the product. It is substantially equivalent to these devices in design, function and operational principles and intended use.
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Image /page/6/Picture/0 description: The image contains the logo for Aspen Imaging Healthcare. The logo consists of a stylized letter "A" with a dot next to it on the left side, followed by the words "ASPEN IMAGING" in a sans-serif font. Below "ASPEN IMAGING" is the word "HEALTHCARE" in a smaller, lighter font. The overall design is clean and modern.
7. Non-Clinical Performance Data
Safety testing and documentation was performed in accordance with IEEE 1012-2012, Standard for System and Software Verification and Validation. [AspenView-SVsR]
Software information is provided in accordance with FDA guidance: "The content of premarket submissions for software contained in medical devices."
Cybersecurity information is provided in accordance with FDA quidance: "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions
8. Conclusions
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification Aspen Imaging Healthcare Inc concludes that AspenView is substantially equivalent to predicate device as described herein.