(77 days)
No
The description focuses on hardware features, workflow automation, and standard image acquisition/processing, with no mention of AI/ML terms or capabilities.
No
The device is described as a "complete stationary diagnostic x-ray system" intended for "obtaining radiographic images," which is a diagnostic purpose, not a therapeutic one.
Yes
The device description explicitly states, "This is a complete stationary diagnostic x-ray system."
No
The device description clearly outlines a complete stationary diagnostic x-ray system with significant hardware components including a ceiling tube suspension, motorized movements, a table, and a high frequency generator, in addition to the image acquisition software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "obtaining radiographic images of various portions of the human body in a clinical environment." This describes an imaging system used on a patient, not a test performed on a sample taken from a patient.
- Device Description: The description details an X-ray system with components like a tube suspension, table, generator, and digital panels. These are all components of an imaging system, not a diagnostic test kit or instrument that analyzes biological samples.
- Input Imaging Modality: The input is X-ray, which is an imaging modality used to visualize internal structures of the body, not to analyze biological samples.
- No mention of analyzing biological samples: There is no mention of the device being used to test blood, urine, tissue, or any other biological sample.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device is clearly an imaging system used for diagnostic purposes through visualization, not through the analysis of biological samples.
N/A
Intended Use / Indications for Use
These are stationary x-ray systems intended for obtaining radiographic images of various portions of the human body in a clinical environment. They are not intended for mammography.
Product codes (comma separated list FDA assigned to the subject device)
KPR, MQB
Device Description
This is a complete stationary diagnostic x-ray system employing digital x-ray panels coupled with image acquisition software. The key features are:
- Ceiling Tube Suspension
- Motorized Movements, Auto-Positioning
- Tube Mounted 10" Touch Screen
- Elevating 6 Way Table Patient Load: 550Ibs
- Single User Interface
- High Frequency Generator
This ergonomic design incorporates automatic motorized positioning, creating an efficient workflow increasing the patient throughput. Precision offers automatic stitching enhancing the workflow further. Tube, vertical wall stand and table have extended range of motion for easy patient positioning. The acquisition software is installed on a Windows compatible workstation. The high frequency generator is available in different power ratings. All components are either 510(k) exempt or previously cleared. Generators are available in 50, 65, 80 kW (High Frequency) models.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray
Anatomical Site
various portions of the human body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinical environment
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)
The modified unit has undergone individual and system performance tests, electrical safety and electromagnetic compatibility testing, as well as software integration validation and risk analysis. The unit meets IEC safety and EMC standards. 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): 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.
Arcoma Intuition, K073632
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.
Canon 40C/G K031633, Canon 50G K031447, Canon 401C K103591, Canon 70C wireless K102012
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.
0
Page 1 of 2
JUN 0 3 2014
510(k) Summary, Device Modification, K14 0 68 3
-
- Submitter: Arcoma AB Annavagen 1 SE-352 46 Vaxjo Sweden Phone: +46 470 70 69 00 Contact/Prepared by: Mikael Larsson, CEO. Date prepared: 17 February 2014
-
- Identification of the Device: 0180 Intuition & 0072 Precision Stationary Digital X-Ray Systems Classification Name: Stationary x-ray system Common/Usual Name: Stationary digital x-ray system Regulation Number: 21 CFR 892.1680 Product Codes: KPR and MQB
-
- Predicate Device: Arcoma Intuition, K073632
- Modification Summary: (1) Newer versions of Canon digital panels will be supplied. (2) A 4. different brand of high frequency generator will be supplied. (3) The overhead tube crane has been motorized. (4) The wall stand now has motorized vertical movement.
-
- A description of the device: This is a complete stationary diagnostic x-ray system employing digital x-ray panels coupled with image acquisition software. The key features are:
- Ceiling Tube Suspension a.
- Motorized Movements, Auto-Positioning ﻗ
- c. Tube Mounted 10" Touch Screen
- Elevating 6 Way Table Patient Load: 5501bs ರ.
- Single User Interface e.
- High Frequency Generator 。
This ergonomic design incorporates automatic motorized positioning, creating an efficient workflow increasing the patient throughput. Precision offers automatic stitching enhancing the workflow further. Tube, vertical wall stand and table have extended range of motion for easy patient positioning. The acquisition software is installed on a Windows compatible workstation. The high frequency generator is available in different power ratings. All components are either 510(k) exempt or previously cleared. Generators are available in 50, 65, 80 kW (High Frequency) models.
-
- These are stationary x-ray systems intended for obtaining radiographic Indications for use: images of various portions of the human body in a clinical environment. They are not intended for mammography.
-
- The 0180 Intuition & 0072 Precision Stationary Digital X-Ray Systems have essentially the same technological characteristics (i.e., design, material, chemical composition, energy source) as the predicate device Arcoma Intuition, K073632. See the comparison table below. There are really only a few main differences: The digital panels, x-ray generator, and tube stands have been modified but have functionally identical capabilities. The proposed new digital x-ray panels each have their own 510(k) clearances.
1
K140683
Page 2 of 2
| Characteristic | Arcoma Intuition, K073632 | 0180 Intuition 0072 Precision |
|---|---|---|
| Indications | The 0170 Intuition is a stationary x-ray | |
| system intended for obtaining | ||
| radiographic images of various portions | ||
| of the human body in a clinical | ||
| environment. The 0170 Intuition is not | ||
| intended for mammography | The 0180 Intuition and 0072 Precision are | |
| stationary digital x-ray systems intended | ||
| for obtaining radiographic images of | ||
| various portions of the human body in a | ||
| clinical environment. They are not | ||
| intended for mammography | ||
| Digital Receptor | ||
| Panel | Canon 40C/G K031633 and | |
| and Canon 50G K031447 | Canon 401C K103591 | |
| and Canon 70C wireless K102012 | ||
| Panel Resolution | Canon 40C/G | |
| Imaging area 43 x 43 cm | ||
| Pixel Pitch 160 $\mu m$ | ||
| Image matrix size 2,688 x 2,688 pixels | ||
| Canon 50G | ||
| Imaging area 35 x 43 cm. | ||
| Pixel Pitch 160 $\mu m$ | ||
| Image matrix size 2,208 x 2,688 pixels | Canon 70C | |
| Imaging area 35 X 43 cm | ||
| Pixel Pitch: 125 $\mu m$ | ||
| Image matrix size: 2,800 x 3,408 Pixels | ||
| Canon 401C | ||
| Effective imaging area: 41.5 × 42.6 cm | ||
| Pixel pitch: 125 $\mu m$ | ||
| Image matrix size: 3320 × 3408 pixels | ||
| Panel Connection | Wired | Wired or Wireless (WiFi) |
| DICOM | Yes | Yes |
| Tube Stand | Ceiling Mount | Same |
| Collimator | Siemens or Ralco | Siemens |
| Generator | EMD EPS 50, 65, 80 kW (High Frequency) | CPI, CMP 200 50, 65, 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: Arcoma Intuition, K073632 | Image: 0180 Intuition 0072 Precision |
- Description of non-clinical tests. The modified unit has undergone individual and system 8. performance tests, electrical safety and electromagnetic compatibility testing, as well as software integration validation and risk analysis. The unit meets IEC safety and EMC standards.
-
- 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.
-
- Conclusions drawn: The nonclinical and clinical tests 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
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three wing-like shapes extending from its body.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Asenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 3. 2014
Arcoma AB % Daniel Kamm, P.E. Kamm & Associates 8870 Ravello Court NAPLES FL 34114
Re: K140683
Trade/Device Name: 0180 Intuition and 0072 Precision Stationary Digital X-Ray Systems Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR Dated: April 29, 2014 Received: May 05, 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 docs 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.
3
Page 2 - Mr. Kamm
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/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.fdg.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.
for
Janine M Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
4
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
510{k) Number (if known) K140683
Device Name
0180 Intuition and 0072 Precision Digital Radiography Systems
Indications for Use (Describe)
These are stationary x-ray systems intended for obtaining radiographic images of various portions of the human body in a clinical environment. The devices are not intended for mammography
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
FORM FDA 3881 (1/14)
PSL" Publiching Seri nees 1 2011 443-4740 H
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