(75 days)
No
The document describes a digital radiographic imaging system with a focus on hardware components and a change in panel size. There is no mention of AI, ML, image processing algorithms, or performance metrics typically associated with AI/ML applications in medical imaging.
No
The device is used to generate radiographic images for diagnosis, not for treating a condition.
Yes
The device is described as "generating radiographic images of human anatomy" and "intended to replace radiographic film/screen systems in general-purpose diagnostic procedures," indicating its role in diagnosis.
No
The device description explicitly lists multiple hardware components (AeroDR Defector, Console CS-7, AeroDR Interface Unit, etc.) that are part of the system.
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 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 details a digital imaging system consisting of a detector, console, and related components used with X-ray systems. This aligns with the description of a medical imaging device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, urine, tissue, etc.), reagents, or any procedures typically associated with in vitro diagnostics.
In summary, the AeroDR SYSTEM with P-21 is a medical imaging device used for generating radiographic images of the human body, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The AeroDR SYSTEM with P-21 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. The AeroDR SYSTEM with P-21 is not indicated for use in mammography, fluoroscopy, tomography and angiography applications.
Product codes
90MQB and 90LLZ, KPR and MQB
Device Description
The AeroDR SYSTEM, K102349 is a digital imaging system to be used with diagnostic x-ray systems. It consists of AeroDR Defector (flat panel digital detector), Console CS-7 (operator console), AeroDR Interface Unit, AeroDR Generator Interface Unit, AeroDR Access Point and AeroDR Battery Charger. Images captured with the flat panel digital detector can be communicated to the operator console via wired connection or wireless, depend on user's choice. The modification was made to the AeroDR SYSTEM with P-21 to add the different panel size. The panel size of 17 x 17 inches (P-21) is added to 17 x 14 inches. The materials of the panel remain unchanged and no other changes were made other than the panel size from 17 x 14 inches to 17 x 17 inches.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray
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)
Performance data from non-clinical testing of the AeroDR SYSTEM with P-21 is compared with data from the predicate device, AeroDR SYSTEM (P-11). This comparison showed that the AeroDR SYSTEM with P-21 performed as well as the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
as required by 807.92
JAN 1 7 2012
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
December 22, 2011
4. Device Trade Name AeroDR SYSTEM with P-21
5. Common Name
Digital Radiography
6. Classification, Product Code
Class II , 90MQB and 90LLZ
7. Predicate Device
AeroDR SYSTEM, 510(k) number K102349 ·
8. Device Description
The AeroDR SYSTEM, K102349 is a digital imaging system to be used with diagnostic x-ray systems. It consists of AeroDR Defector (flat panel digital detector), Console CS-7 (operator console), AeroDR Interface Unit, AeroDR Generator Interface Unit, AeroDR Access Point and AeroDR Battery Charger. Images captured with the flat panel digital detector can be communicated to the operator console via wired connection or wireless, depend on user's choice. The modification was made to the AeroDR SYSTEM with P-21 to add the
3 - B - 1
1
ae 20f-2 KI13248 different panel size. The panel size of 17 x 17 inches (P-21) is added to 17 x 14 inches. The materials of the panel remain unchanged and no other changes were made other than the panel size from 17 x 14 inches to 17 x 17 inches.
9. Indications for Use
The AeroDR SYSTEM with P-21 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. The AeroDR SYSTEM with P-21 is not indicated for use in mammography, fluoroscopy, tomography and angiography applications.
10. Performance Testing
Performance data from non-clinical testing of the AeroDR SYSTEM with P-21 is compared with data from the predicate device, AeroDR SYSTEM (P-11). This comparison showed that the AeroDR SYSTEM with P-21 performed as well as the predicate device.
11. Substantial Equivalence to Predicate Device
The Indications for Use of proposed device and predicate devices are identical. The materials of the panel remain unchanged. The results of performance testing shows that there is no new safety and efficacy issue of the proposed device introducing those already have identified with the predicate device. The proposed device, AeroDR SYSTEM with P-21 is substantial equivalent to the predicate device, AeroDR SYSTEM.
12. Safety Information
The AeroDR SYSTEM with P-21 has been tested and shown to meet the requirements of IEC 60601-1 and IEC 60601-1-2.
The Risk Analysis for the AeroDR with P-21 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.
13. Conclusion
Comprehensively, we judged that the AeroDR SYSTEM with P-21 has the same technological characteristics as the predicate devices. This 510(k) has demonstrated substantial equivalence as the predicate devices.
3 - B - 2
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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The logo includes a symbol on the left side, which is a blue emblem. To the right of the emblem, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is written in blue, with the words spread out across the image.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Konica Minolta Medical & Graphic, Inc. % Mr. Russel Munves Official Correspondent Storch, Amini & Munves, P.C. 140 East 45th Street 25th Floor, Two Grand Central Tower NEW YORK NY 10017
AUG 20 2013
Re: K113248
Trade/Device Name: AeroDR SYSTEM with P-21 Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR and MQB Dated: December 22, 2011 Received: December 23, 2011
Dear Mr. Munves:
This letter corrects our substantially equivalent letter of January 17, 2012.
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
3
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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K113248
Page 1 of 1
Indications for Use
KII3248 510(k) Number (if known)
Device Name AeroDR SYSTEM with P-21 .
Indications for Use:
The AeroDR SYSTEM with P-21 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.
The AeroDR SYSTEM with P-21 is not indicated for use in mammography, fluoroscopy, tomography and angiography applications.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Mary S. Patil
Division Sigh-off Office of In Vitro Diagnostic Devices Evaluation and Safety
510(k) K113248