(53 days)
Not Found
No
The summary focuses on the software's function in eliminating the need for a physical connection to the X-ray generator and detecting irradiation, with no mention of AI/ML terms or capabilities.
No.
The device is used for generating radiographic images for diagnostic procedures, which is not a therapeutic use.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended to replace radiographic film/screen systems in general-purpose diagnostic procedures."
Yes
The device is explicitly described as a "software device" and its function is to enhance an existing hardware system (AeroDR SYSTEM) by eliminating a physical connection, indicating its role is purely software-based control and data handling within the existing imaging workflow.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used for "generating radiographic images of human anatomy" and is intended to "replace radiographic film/screen systems in general-purpose diagnostic procedures." This describes an imaging device used for diagnostic purposes on the patient, not a device used to examine specimens in vitro (outside the body).
- Device Description: The description focuses on the software's function in conjunction with the AeroDR SYSTEM to capture X-ray images without a cable connection. This further reinforces its role in the imaging process.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other activities typically associated with in vitro diagnostics.
Therefore, the AeroSync for AeroDR SYSTEM is a medical imaging software device, not an IVD.
N/A
Intended Use / Indications for Use
The AeroSync for AeroDR SYSTEM is a software device that is used in conjunction with AeroDR SYSTEM. This device is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in general-purpose diagnostic procedures.
This device is not indicated for use in mammography, fluoroscopy, tomography and angiography applications.
Product codes (comma separated list FDA assigned to the subject device)
90MQB, 90LLZ
Device Description
The AeroSync for AeroDR SYSTEM is a software device that is used in conjunction with our AeroDR SYSTEM, K102349. It adds minor change for our cleared AeroDR SYSTEM. It eliminates the need for an electrical connection between the AeroDR SYSTEM and X-ray generator. It can be detected X-ray irradiation without cables connected to X-ray generator.
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
Not Found
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 results of performance testing shows that the image quality of proposed device is equivalent to the predicate device.
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.
Not Found
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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510(k) Summary
APR - 9 2012
as required by 807.92
1. Company Identification
Konica Minolta Medical & Graphic, Inc. No.1 Sakura-machi, Hino-shi, Tokyo 191-8511, Japan Establishment Registration Number: 3004485675
2. Submitter's Name and Address
Shigeyuki Kojima
Manager
Regulations and Standards Section, Quality Assurance Center No. 1 Sakura-machi, Hino-shi, Tokyo 191-8511, Japan Telephone: 81-42-589-8429 Fax: 81-42-589-8053
3. Date of Submission
February 10, 2012
4. Device Trade Name
AeroSync for AeroDR SYSTEM
5. Common Name
Digital Radiography
6. Classification, Product Code
Class II, 90MQB and 90LLZ
7. Predicate Device
AeroDR SYSTEM, 510(k) number K102349
8. Indications for Use
The AeroSync for AeroDR SYSTEM is a software device that is used in conjunction with AeroDR SYSTEM. This device is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in general-purpose diagnostic procedures.
This device is not indicated for use in mammography, fluoroscopy, tomography and angiography applications.
1
9. Device Description
The AeroSync for AeroDR SYSTEM is a software device that is used in conjunction with our AeroDR SYSTEM, K102349. It adds minor change for our cleared AeroDR SYSTEM. It eliminates the need for an electrical connection between the AeroDR SYSTEM and X-ray generator. It can be detected X-ray irradiation without cables connected to X-ray generator.
10. Risk Analysis
The Risk Analysis for the AeroSync for AeroDR System (X-ray perception software) was conducted on the basis of ISO14971, "Medical devices – Application of risk management to medical devices". As a result of risk control measures, the risk associated with all of the identified hazards was reduced to an acceptable level or ALARP (As low as reasonably practicable).
Please refer to Section 13, Appendix-G
11. Compliance of Recognized Consensus Standard
In terms of Indications for use of this AeroSync for AeroDR SYSTEM, it has been tested and shown to meet the requirements of IEC 60601-1 and IEC 60601-1-2 as follows. Please refer to the Section 7, STANDARD DATA REPORTS FOR 510(k)s.
Safety standard: IEC60601-1 Ed.2 (1988) + A1 (1991)+A2(1995)
Electromagnetic Compatibility: IEC60601-1-2 Ed.3 (2007)
Besides, AeroSync for AeroDR SYSTEM includes RF wireless technologies (which customer can select), so that to ensure safety of device in case of wireless use, it also has been tested and shown to meet the requirements of FCC part15 Subpart C,E.
12. Substantial Equivalence to Predicate Device
The predicate devices of AeroSync for AeroDR SYSTEM is our AeroDR SYSTEM, K102349.
The proposed device is a minor changed system of our cleared AeroDR SYSTEM. It eliminates the need for an electrical connection between the AeroDR SYSTEM and X-ray generator.
A comparison of the Indications for Use, Configuration, Specifications and Principals of operation by this proposed device and the predicate device has shown in Section 9, Substantial Equivalence Comparison Table.
The result of the Section 9, above mentioned the Risk Analysis and the
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Compliance of Recognized Consensus Standard showed that there is no new safety and efficacy issue of the proposed device. Also, the results of performance testing shows that the image quality of proposed device is equivalent to the predicate device. Please refer to the section 14 and 15 Performance Testing.
The AeroSync for AeroDR SYSTEM is substantially equivalent to AeroDR SYSTEM, 510(k) Number, K102349.
9. Conclusion
Comprehensively, we conclude that the AeroSync for AeroDR System has the same technological characteristics as the predicate device. This 510(k) has demonstrated substantial equivalence as the predicate device.
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The text is in all capital letters and is black.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
APR - 9 2012
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Konica Minolta Medical & Graphics, Inc. % Mr. Ressell Munves Consultant Storch, Amini & Munves, P.C. 140 East 45th Street, 25th Floor Tow Grand Tower NEW YORK NY 10017
Re: K120477
Trade/Device Name: AeroSync for AeroDR SYSTEM Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: MQB Dated: February 14, 2012
Received: February 16, 2012
Dear Mr. Munves:
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.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of
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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 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/cdrh/industry/support/index.html.
Sincerely Yours,
Janine M. Morris
Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
AeroSync for AeroDR SYSTEM Device Name
Indications for Use:
The AeroSync for AeroDR SYSTEM is a software device that is used in conjunction with AeroDR SYSTEM. This device is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in general-purpose diagnostic procedures.
This device is not indicated for use in mammography, fluoroscopy, tomography and angiography applications.
Prescription Use X (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Rummellious
Jivision Sign-off Office of In Vitro Diagnostic Devices Evaluation and Safety
510(k) K.120477