(112 days)
No
The summary describes a standard digital x-ray system with image acquisition software. There is no mention of AI, ML, or any advanced image processing features that would suggest the use of these technologies. The performance studies focus on electrical safety, EMC, software validation, risk analysis, and image quality evaluation by radiologists, which are typical for conventional x-ray systems.
No
The device is described as a "complete stationary diagnostic x-ray system" used for "taking diagnostic radiographic exposures," indicating its purpose is for diagnosis, not therapy.
Yes
Explanation: The "Intended Use / Indications for Use" states the device is "for taking diagnostic radiographic exposures". The "Device Description" also refers to it as a "complete stationary diagnostic x-ray system".
No
The device description explicitly states it is a "complete stationary diagnostic x-ray system employing a digital x-ray panel coupled with image acquisition software" and includes hardware components like a high frequency generator and tube stand.
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 "taking diagnostic radiographic exposures" of various body parts. This is a process that happens in vivo (within the living body) to produce images for diagnosis.
- Device Description: The description details a "stationary diagnostic x-ray system" that uses a digital x-ray panel and image acquisition software. This is consistent with medical imaging equipment used to visualize internal structures of the body.
- Lack of IVD Characteristics: IVD devices are typically used to examine specimens (like blood, urine, or tissue) in vitro (outside the living body) to provide information for diagnosis. The description and intended use of this device do not involve the analysis of biological specimens.
The device is a medical imaging system used for diagnostic purposes, but it operates by generating and capturing X-rays of the patient's body, not by analyzing samples in a lab setting.
N/A
Intended Use / Indications for Use
Intended for use by a qualified/trained doctor or technician on both adult and pediatric 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)
Product codes
MQB, KPR
Device Description
This is a complete stationary diagnostic x-ray system employing a digital x-ray panel coupled with image acquisition software. The acquisition software is installed on a Windows compatible workstation. The high frequency generator is available in four different power ratings. All components are either 510(k) exempt or previously cleared. The only difference between the two models is the configuration of the tube stand. Galaxy has a straight arm and the Galaxy+ Plus is in a U-Arm configuration. Generators are available in 40-50-65-or 80 kW (High Frequency) models.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-Ray
Anatomical Site
skull, spinal column, chest, abdomen, extremities, and other body parts
Indicated Patient Age Range
adult and pediatric subjects
Intended User / Care Setting
qualified/trained doctor 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical tests: The unit has undergone electrical safety and electromagnetic compatibility testing, as well as software validation and risk analysis. The unit meets IEC safety and EMC standards. The technical characteristics of the new system have been measured and included in the bench testing information performed by a radiology physicist.
Clinical tests: Clinical images were obtained in accordance with the FDA Guidance Document on Solid State Imaging Devices. They were evaluated by professional radiologist and found to be of good diagnostic quality.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
Page 1 of 2.
510(k) Summary K132294
- Submitter: RADIOLOGY SOLUTIONS LLC 1912 Golfcrest Dr Commerce Twp, MI 48382 Tel. 866.681.6681 Date Prepared: October 10, 2013 Contact: Scott Milgrom, President
NOV 1 2 2013
-
- Identification of the Device: Galaxy and Galaxy+ Plus Digital Diagnostic X-Ray System. Classification Name: Stationary x-ray system ; Common/Usual Name: Stationary x-ray system Regulation Numbers: 21 CFR 892.1680, Product Codes: MQB and KPR
- Predicate Device: The Galaxy systems are substantially equivalent to The Sedecal X-Plus LP Plus 3. Digital Diagnostic X-Ray Systems, K090238.
- A description of the device: This is a complete stationary diagnostic x-ray system employing a digital 4. x-ray panel coupled with image acquisition software. The acquisition software is installed on a Windows compatible workstation. The high frequency generator is available in four different power ratings. All components are either 510(k) exempt or previously cleared. The only difference between the two models is the configuration of the tube stand. Galaxy has a straight arm and the Galaxy+ Plus is in a U-Arm configuration. Generators are available in 40-50-65-or 80 kW (High Frequency) models.
- ട. Indications for Use: Intended for use by a qualified/trained doctor or technician on both adult and pediatric 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)
- The Galaxy and Galaxy Plus have essentially the same technological characteristics (i.e., design, ર. 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.
| Characteristic | Predicate Device | Galaxy and Galaxy+ Plus |
|---|---|---|
| The Sedecal X-Plus LP Plus Digital Diagnostic | ||
| X-Ray Systems, K090238. | ||
| Indications | Intended for use by a qualified/trained doctor or | |
| technician on both adult and pediatric 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. | Intended for use by a qualified/trained doctor | |
| or technician on both adult and pediatric | ||
| 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) | ||
| Digital Receptor | ||
| Panel | CANON panels, multiple models: 50C, 50G, 40C | |
| & 40G (Various clearances) | Atlaim ATAL 8 AND ATAL 8C (Cleared in | |
| K113812) to be known as "IRIS" AND "IRIS C" | ||
| Characteristic | Predicate Device | |
| The Sedecal X-Plus LP Plus Digital Diagnostic | ||
| X-Ray Systems, K090238. | Galaxy and Galaxy+ Plus | |
| Panel | ||
| Communication | Tethered Ethernet, one panel | Same |
| Panel | ||
| Resolution | Pixel size160 × 160 μm | |
| Image matrix size2208 × 2688 pixels | ||
| Number of pixels Approx. 5.9 million pixels | Pixel size 139 x 139 μm | |
| Image matrix size 3072 x 3072 pixels | ||
| Number of pixels Approx. 9.4 million pixels | ||
| DICOM | Yes | Yes (Same software as cleared in K112527) to |
| be known as "Nexxus" | ||
| Tube Stand | U-Arm | One model is a straight arm, the other is similar |
| to a U-Arm. See below | ||
| Generator | Sedecal 65 kW, optional 80 kW (High frequency) | CPI, 40-50-65-or 80 kW (High Frequency) |
| Safety | UL Listings and IEC Standards IEC 60601-1 and | |
| IEC 60601-1-2, US Performance Standards | UL/CSA Listings and IEC Standards IEC 60601-1 | |
| and IEC 60601-1-2, US Performance Standards | ||
| Photo | Image: Sedecal X-Plus LP Plus Digital Diagnostic X-Ray Systems | Image: Galaxy |
| Image: Galaxy+ Plus |
1
-
- Description of non-clinical tests. The unit has undergone electrical safety and electromagnetic compatibility testing, as well as software validation and risk analysis. The unit meets IEC safety and EMC standards. The technical characteristics of the new system have been measured and included in the bench testing information performed by a radiology physicist.
-
- Description of clinical tests. Clinical images were obtained in accordance with the FDA Guidance Document on Solid State Imaging Devices. They were evaluated by professional radiologist and found to be of good diagnostic quality.
- ਰੇ. Conclusions drawn: The nonclinical and clinical tests that demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed device identified in paragraph 3, above.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows a circular seal with text around the perimeter and a symbol in the center. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The symbol in the center appears to be a stylized representation of a person or figure, possibly with flowing lines or ribbons.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring MD 20993-0002
November 12, 2013
Radiology Solutions LLC % Daniel Kamm, P.E. Principal Engineer Kamm & Associates 8870 Ravello Court NAPLES FL 34114
Re: K132294
Trade/Device Name: Galaxy and Galaxy+ Plus Digital Radiography Systems Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR and MQB Dated: August 12, 2013 Received: August 15, 2013
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 for ass sured in the energenent date of the enactment date of the Medical Device Amendments, or to connities that have been reclassified in accordance with the provisions of the Federal Food, Drug, ue necs that have occh roulabilities in assire approval of a premarket approval application (PMA). and Cosinctic Act (Act) that to norice, subject to the general controls provisions of the Act. The 1 ou may, dierelove, manov of the Act include requirements for annual registration, listing of general controls provisions of ractice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability additeration. Thease note: CDTCP acce not evaluate mast be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (bee 2001). Existing major regulations affecting your device can be may be subject to additional controls. "Encling any and 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 Please be advised hat I DA 3 issualled of a complies with other requirements of the Act ulat I DA has made a decorminations administered by other Federal agencies. You must of any I edefal statutes and regarantents, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical CFK Fart 807), labeling (21 CFR 803); montal en anufacturing practice requirements as set
3
Page 2 - Mr. Kamm
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/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 Small Manufacturers. International and Consumer Assistance 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.
Sincerely yours.
Smh 7)
l'or
Janine M. Morris Director. Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K132294
Device Name: Galaxy and Galaxy+ Plus
Indications for Use:
Intended for use by a qualified/trained doctor or technician on both adult and pediatric 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)
Prescription Use X
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(Please DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Smh
(Division Sign-Off)
Division of Radiological Health
Office of In Vitro Diagnostics and Radiological Health
K132294 510(k)
Page 1 of 1