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K Number
K120752
Device Name
AERODR STITCHING SYSTEM
Manufacturer
KONICA MINOLTA MEDICAL & GRAPHIC, INC.
Date Cleared
2012-06-08

(88 days)

Product Code
KPR
Regulation Number
892.1680
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The AeroDR Stitching System is used with Konica Minolta AeroDR SYSTEM which 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 used for examinations of long areas of anatomy such as the leg and spine. This device is not indicated for use in mammography, fluoroscopy, tomography and angiography applications.
Device Description
The AeroDR Stitching System is used with 510(k) cleared Konica Minolta AeroDR SYSTEM (K102349) which is indicated for use in generating radiographic images of human anatomy. The AeroDR Stitching System is an accessory of stationary X-ray system which extends the capability of the AeroDR SYSTEM to allow the capture of long length images with an image area up to 1196mm x 349mm. It consists of AeroDR Stitching Unit, AeroDR Stitching X-ray Auto Barrier Unit and Power Supply Unit. The AeroDR Detecter (K102349) loaded in the AeroDR Stitching Unit takes up to 3 images and transfer them to the Console CS-7 (K102349). Combining the transferred images in the CS-7 enables diagnosis of long images.
More Information

K051998

K102349

No
The document describes image processing for stitching multiple images but does not mention AI, ML, or related terms like deep learning or neural networks. The focus is on combining images, which is a standard image processing technique.

No.
The device is used for diagnostic imaging (generating radiographic images) and not for treating or alleviating a disease or condition.

No
The device is used for generating radiographic images for diagnostic procedures, but it is an imaging system, not a diagnostic device itself. It produces images that enable diagnosis.

No

The device description explicitly states it consists of hardware components: AeroDR Stitching Unit, AeroDR Stitching X-ray Auto Barrier Unit, and Power Supply Unit. While it includes software for image processing, it is not solely software.

Based on the provided text, the AeroDR Stitching System is not an IVD (In Vitro Diagnostic) device.

Here's why:

  • IVD devices are used to examine specimens taken from the human body. The description of the AeroDR Stitching System clearly states its purpose is to generate and combine radiographic images of human anatomy (leg and spine) using X-rays. This involves imaging the body directly, not analyzing samples taken from the body.
  • The intended use and device description focus on imaging and image processing. The text describes capturing X-ray images, transferring them, and combining them for diagnosis. This aligns with medical imaging devices, not IVD devices.

Therefore, the AeroDR Stitching System falls under the category of a medical imaging device, specifically an accessory for a radiographic system, rather than an In Vitro Diagnostic device.

N/A

Intended Use / Indications for Use

The AeroDR Stitching System is used with Konica Minolta AeroDR SYSTEM which 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 used for examinations of long areas of anatomy such as the leg and spine. 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)

KPR

Device Description

The AeroDR Stitching System is an accessory of stationary X-ray system which extends the capability of the AeroDR SYSTEM to allow the capture of long length images with an image area up to 1196mm x 349mm. It consists of AeroDR Stitching Unit, AeroDR Stitching X-ray Auto Barrier Unit and Power Supply Unit.

The AeroDR Detecter (K102349) loaded in the AeroDR Stitching Unit takes up to 3 images and transfer them to the Console CS-7 (K102349). Combining the transferred images in the CS-7 enables diagnosis of long images.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Radiographic images

Anatomical Site

Leg and spine, long areas of human anatomy

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Clinic, radiology department in a hospital and in other medical facilities.

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

Performance testing was conducted to verify the design output met the design input requirements and to validate AeroDR Stitching SYSTEM conformed to the defined user needs and intended uses upon the quality of the device software. Through validation results of sample images and non-clinical testing under simulated use conditions, safe, effectiveness and performances are confirmed the achievement of predefined acceptance criteria, as well as substantially equivalence to the predicate device, besides product safety and electromagnetic compatibility.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Performance testing was conducted to verify the design output met the design input requirements and to validate AeroDR Stitching SYSTEM conformed to the defined user needs and intended uses upon the quality of the device software. Through validation results of sample images and non-clinical testing under simulated use conditions, safe, effectiveness and performances are confirmed the achievement of predefined acceptance criteria, as well as substantially equivalence to the predicate device, besides product safety and electromagnetic compatibility.

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.

K051998

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.

K102349

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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K120752

510(k) Summary

as required by 807.92

JUN - 8 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

    1. Date of Submission
      March 9, 2012
    1. Device Trade Name AeroDR Stitching System
    1. Classification, Product Code Class II, 21CFR892.1680, 90 KPR

6. Predicate Device

REGIUS MODEL 170. 510(k) number K051998

7. Indications for Use

The AeroDR Stitching System is used with Konica Minolta AeroDR SYSTEM which 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 used for examinations of long areas of anatomy such as the leg and spine. This device is not indicated for use in mammography, fluoroscopy, tomography and angiography applications.

8. Device Description

The AeroDR Stitching System is used with 510(k) cleared Konica Minolta AeroDR SYSTEM (K102349) which is indicated for use in generating radiographic images of human anatomy.

The AeroDR Stitching System is an accessory of stationary X-ray system which

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extends the capability of the AeroDR SYSTEM to allow the capture of long length images with an image area up to 1196mm x 349mm. It consists of AeroDR Stitching Unit, AeroDR Stitching X-ray Auto Barrier Unit and Power Supply Unit.

The AeroDR Detecter (K102349) loaded in the AeroDR Stitching Unit takes up to 3 images and transfer them to the Console CS-7 (K102349). Combining the transferred images in the CS-7 enables diagnosis of long images.

9. Risk Analysis (Summary of Design Control Activities)

The Risk Analysis for the AeroDR Stitching System 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).

10. Compliance of Recognized Consensus Standard

In terms of Indications for use of this AeroDR Stitching System, it has been tested and · shown to meet the requirements of IEC 60601-1 and IEC 60601-1-2 as follows. Safety standard: IEC60601-1 Ed.2 (1988) + A1 (1991)+A2(1995) Electromagnetic Compatibility: IEC60601-1-2 Ed.3(2007)

11. Substantial Equivalence to Predicate Device

The predicate device is our REGIUS MODEL 170, 510(k) number K051998. Both AeroDR Stitching System and the predicate are used for examinations of long areas of anatomy such as the leg and spine.

Comparison of the principal characteristics of these devices, please refer to the Substantial Equivalence Comparison Table as follows.

Medical Device Applied for Clearar
Applicant, etc.Company : KonicaMinoIta MedicalCompany: KonicaMinoIta Medical &Graphic.
&Graphic, Inc.Inc.
Product Name : REGIUS MODEL 170Product Name: AeroDR Stitching System
CR cassette:RC-110T/RC-110R
K Number : K051198
ConfigurationThe REGIUS MODEL 170 is an X-rayThe AeroDR Stitching System is used with
image reader which uses a stimulable510(k) cleared Konica Minolta AeroDR
phosphor plate (Plate) as X-ray detectorSYSTEM (K102349).
installed in a separate cassette.The AeroDR Stitching System extends the
The REGIUS MODEL 170 consists of
REGIUS MODEL 170 image reader and CR
Cassette / Plate.
It reads the image recorded on the Plate
and transfers the image data to an
externally connected device such as
Console CS3000 (K051523).
Using the CR cassette with multiple (three)
stimulable phosphor plates aligned along
the long side, latent images are produced,
and the visual image is generated by
scanning with a separate reader device.
Combining the transferred images in the
CS3000 enables diagnosis of long images.capability of the AeroDR SYSTEM to allow
the capture of long length images.
AeroDR Stitching System consists of
AeroDR Stitching Unit, AeroDR Stitching
X-ray Auto Barrier Unit and Power Supply
Unit.
The AeroDR Detecter (K102349) loaded in
the AeroDR Stitching Unit takes up to three
images and transfers them to the Console
CS-7 (K102349). Combining the transferred
images in the CS-7 enables diagnosis of long
images.
Principle of
OperationUsing the CR cassette with multiple
stimulable phosphor plates aligned along
the long side, position the cassette at the
back of the patient and make a single X-ray
exposure over the necessary area. Reload
the exposed image into the other cassettes,
and feed these cassettes into the reader
device in order so that the image is
independently scanned and multiple
images are stitched and displayed on the
console by the image processing.Position the AeroDR Stitching unit at the back
of the patient. The AeroDR Stitching System
produces long length images of subjects by
moving a 14 x 17 inch AeroDR Detector up
and down inside the AeroDR Stitching Unit
and takes up to 3 images. Transfer these
multiple images to the Console CS-7
(K102349) and stitch multiple images by
image processing on the console.
SpecificationsREGIUS MODEL 170
CR cassette:RC-110T
  1. Vertical Exposure range
    14×42inch (14×14×3plates)
    11×24inch (11×12×2plates)
    10×36inch (10×12×3plates)
    14×51inch (14×17×3plates)
  2. Sampling Pitch : 87.5/175μm
    3)Operation Environment
    Temperature : 1530 C
    Humidity : 30    80%RH | AeroDR Detector (K102349) : 14×17inch
    FPD
    Pixel Size: 175μ
    AeroDR Stitching System (Device)
  3. Vertical Exposure range
    SID=2.4m : Max. 50"(3shoots)
    SID=2.0m : Max. 41"(2shoots)
    SID=1.5m : Max. 31"(2shoots)
    Width 14inch only
    2)Operation Environment
    Temperature : 1530 C
    Humidity : 30    80%RH |
    | Indications for
    Use | The Direct Digitizer, REGIUS MODEL 170
    is an X-ray image reader which uses a
    stimulable phosphor plate (Plate) as X-ray
    detector installed in a separate cassette. It | The AeroDR Stitching System is used with
    Konica Minolta AeroDR SYSTEM which is
    indicated for use in generating radiographic
    images of human anatomy. It is intended to |
    | reads the image recorded on the Plate and
    transfers the image data to an externally
    connected device such as a host computer,
    an order input device, an image display
    device, a printer, an image data filing
    device, and other image reproduction
    devices.
    REGIUS MODEL 170 is used to obtain
    image data of long areas of anatomy such
    as the whole spine or the whole lower leg.
    REGIUS MODEL 170 is also used to obtain
    image data to verify the position for a
    radiotherapy location.
    It is designed intended to use in a clinic, a
    radiology department in a hospital and in
    other medical facilities. It is not intended for
    use with digital mammography system. | replace radiographic film/screen systems in
    general-purpose diagnostic procedures.
    This device is used for examinations of long
    areas of anatomy such as the leg and spine.
    This device is not indicated for use in
    mammography, fluoroscopy, tomography
    and angiography applications. | |

AeroDR Stitching System Substantial Equivalence Comparison Table

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:

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12. Performance-Testing

Performance testing was conducted to verify the design output met the design input requirements and to validate AeroDR Stitching SYSTEM conformed to the defined user needs and intended uses upon the quality of the device software. Through validation results of sample images and non-clinical testing under simulated use conditions, safe, effectiveness and performances are confirmed the achievement of predefined acceptance criteria, as well as substantially equivalence to the predicate device, besides product safety and electromagnetic compatibility.

13. Conclusion

Comprehensively, we judged that the AeroDR Stitching System has the same technological characteristics as the predicate devices. This 510(k) has demonstrated substantial equivalence as the predicate devices.

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Image /page/4/Picture/0 description: The image shows the seal for the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is a stylized image of an eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

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 General Tower NEW YORK NY 10017

Re: K120752

Trade/Device Name: AeroDR Stitching System Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II . Product Code: KPR Dated: May 22, 2012 Received: May 23, 2012

JUN - 8 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 nredicate 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

6

Indications for Use

510(k) Number (if known)

: KI20752

Device Name

AeroDR Stitching System

Indications for Use:

The AeroDR Stitching System is used with Konica Minolta AeroDR SYSTEM which 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 used for examinations of long areas of anatomy such as the leg and spine. This device is not indicated for use in mammography, fluoroscopy, tomography and angiography applications.

Prescription Use_ × (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)

Arshad D'Silva

Division Sign-off Office of In Vitro Diagnostic Devices Evaluation and Safety

510(k) K120752