(95 days)
No
The description focuses on hardware and basic image acquisition/calibration features, with no mention of AI/ML terms or functionalities.
No
This device is an imaging system designed to generate radiographic images for diagnostic purposes, not to treat or alleviate a medical condition.
Yes.
The "Intended Use / Indications for Use" states that the device is intended for use "in all general purpose diagnostic procedures."
No
The device description explicitly states it is a "digital x-ray panel coupled with image acquisition software," indicating the presence of hardware (the digital x-ray panel) in addition to the software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to generate radiographic images of human anatomy for general purpose diagnostic procedures. This involves imaging the internal structures of the body using X-rays.
- Device Description: The device is a digital X-ray panel and image acquisition software. It captures X-ray images.
- Nature of IVDs: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
This device operates by capturing images of the body itself, not by analyzing samples taken from the body. Therefore, it falls under the category of medical imaging devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
This flat panel digital imaging system is intended for use in generating radiographic images of human anatomy. This device is intended to replace film/screen systems in all general purpose diagnostic procedures. This device is intended for use by qualified medical personnel. (Not for mammography)
Product codes (comma separated list FDA assigned to the subject device)
MOB
Device Description
This is a digital x-ray panel coupled with image acquisition software. The acquisition software is installed on a Windows compatible workstation. No routine user calibration or generator connection is reguired. Problems which ensue when system is depended upon for timing...the most crucial part in the digital Image creation... are eliminated. These are the vast majority of service issues in DR retrofits. AED and ACC are standard features. AED is automatic exposure detection. No synchronization connection to the generator is required. ACC is Automatic Calibration Control. Calibration values are automatically loaded at power-up. The TFT is inherently linear, and all that is necessary is to set a Start (Dark) and Stop (Bright) value to define the dynamic range you want to operate in. It is completely independent of the x-ray source. That is why this can be done at the factory. MECHANICAL: FITS IN THE BUCKY TRAY WITHOUT MODIFICATION... Ultra-Light Cassette Sized Detector easily moves from table top to wall to stretcher with ease. The system is compatible with CPI CMP 200 and Sedecal SHF series generators. Testing has not been conducted regarding compatibility with other generators.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human anatomy
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified medical personnel
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)
No new testing was done because no modifications have been made other than deleting the generator and tube stand. The nonclinical tests performed in our previous clearance demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed device that was our original predicate.
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
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three overlapping profiles, suggesting a sense of community or interconnectedness. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 3, 2014
RADIOLOGY SOLUTIONS LLC % Daniel Kamm, P.E. Principal Engineer Kamm & Associate 8870 Ravello Court NAPLES FL 34114
Re: K141743
Trade/Device Name: Fusion Digital Diagnostic X-ray Upgrade Kit Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MOB Dated: September 1, 2014 Received: September 4, 2014
Dear Mr. Kamm:
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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Smhff)
for
Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K141743
Device Name FUSION DIGITAL X-RAY DETECTOR (upgrade kit)
Indications for Use (Describe)
This flat panel digital imaging system is intended for use in generating radiographic images of human anatomy. This device is intended to replace film/screen systems in all general purpose diagnostic procedures. This device is intended for use by qualified medical personnel. (Not for mammography)
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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510(k) Summary - K141743
-
- Submitter: RADIOLOGY SOLUTIONS LLC 1912 Golfcrest Dr Commerce Twp, MI 48382 Tel. 866.681.6681 Date Prepared: September 19, 2014 Contact: Scott Milgrom, President
-
- Identification of the Device: Fusion Digital Diagnostic X-Ray Upgrade Kit. Classification Name: Stationary X-ray system Common/Usual Name: Digital X-ray Panel (upgrade kit) Regulation Numbers: 21 CFR 892.1680; Product Code: MQB
-
- Predicate Device: Fusion Digital Diagnostic X-Ray Upgrade Kit uses the IDENTICAL digital x-ray panel/software/workstation that was cleared in K132294. The only difference is the generator and tubestand is not supplied.
-
- A description of the device: This is a digital x-ray panel coupled with image acquisition software. The acquisition software is installed on a Windows compatible workstation. No routine user calibration or generator connection is reguired. Problems which ensue when system is depended upon for timing...the most crucial part in the digital Image creation... are eliminated. These are the vast majority of service issues in DR retrofits. AED and ACC are standard features. AED is automatic exposure detection. No synchronization connection to the generator is required. ACC is Automatic Calibration Control. Calibration values are automatically loaded at power-up. The TFT is inherently linear, and all that is necessary is to set a Start (Dark) and Stop (Bright) value to define the dynamic range you want to operate in. It is completely independent of the x-ray source. That is why this can be done at the factory. MECHANICAL: FITS IN THE BUCKY TRAY WITHOUT MODIFICATION... Ultra-Light Cassette Sized Detector easily moves from table top to wall to stretcher with ease. The system is compatible with CPI CMP 200 and Sedecal SHF series generators. Testing has not been conducted regarding compatibility with other generators.
- ഗ് Intended use of the device: This flat panel digital imaging system is intended for use in generating radiographic images of human anatomy. This device is intended to replace film/screen systems in all general purpose diagnostic procedures. This device is intended for use by qualified medical personnel. (Not for mammography)
-
- The Galaxy and Galaxy Plus have essentially the same technological characteristics (i.e., design, material, chemical composition, energy source) as the predicate device Sedecal. See the comparison table below. There are really only a few main differences: The digital panels, x-ray generator, and tube stands are from different manufacturers but with functionally identical capabilities.
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Comparison Table
| Characteristic | Galaxy and Galaxy+ Plus K132294 | Fusion Digital Diagnostic X-Ray Upgrade Kit. |
|---|---|---|
| Indications | Intended for use by a qualified/trained doctor | |
| or technician on 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) | This flat panel digital imaging system is | |
| intended for use in generating radiographic | ||
| images of human anatomy. This device is | ||
| intended to replace film/screen systems in all | ||
| general purpose diagnostic procedures. This | ||
| device is intended for use by qualified medical | ||
| personnel. (Not for mammography) | ||
| Digital Receptor | ||
| Panel | Atlaim ATAL 8 AND ATAL 8C (Cleared in | |
| K113812) to be known as "IRIS" AND "IRIS C" | SAME | |
| Panel | ||
| Communication | Tethered Ethernet, one panel | SAME |
| Panel | ||
| Resolution | Pixel size 139 x 139 μm | |
| Image matrix size 3072 x 3072 pixels | ||
| Number of pixels Approx. 9.4 million pixels | SAME | |
| DICOM | Yes (Same software as cleared in K112527) to | |
| be known as "Nexxus" | SAME | |
| Tube Stand | Same | NOT SUPPLIED |
| Generator | CPI, 40-50-65-or 80 kW (High Frequency) | NOT SUPPLIED but compatible with CPI CMP |
| 200 and Sedecal SHF series generators. | ||
| Safety | UL/CSA Listings and IEC Standards IEC 60601-1 | |
| and IEC 60601-1-2, US Performance Standards | SAME | |
| Photo | Image: Galaxy+ Plus | Image: Digital Receptor Panel |
- Description of non-clinical tests. No new testing was done because no modifications have been 7. made other than deleting the generator and tube stand.
-
- Description of clinical tests. No new testing was done because no modifications have been made other than deleting the generator and tube stand.
-
- Conclusions drawn: The nonclinical tests performed in our previous clearance demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed device that was our original predicate. Installation of the upgrade kit must be done by a qualified service technician and performance should be verified by the facility radiation physicist.