(99 days)
Not Found
No
The description focuses on image stitching and manual editing, with no mention of AI or ML terms or concepts.
No.
The device is a software component for a diagnostic x-ray system that processes images and does not provide any therapeutic intervention.
Yes
The "Device Description" explicitly states, "The DR Long Length Imaging Software is a software component for use on a diagnostic x-ray system utilizing digital radiography (DR) technology." Additionally, under "Summary of Performance Studies," it mentions, "Clinical testing was conducted to evaluate the acceptability of the composite images for diagnostic use."
Yes
The device is described solely as a software component that processes images from a separate hardware system (diagnostic x-ray system utilizing digital radiography). There is no mention of any hardware being part of the device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The described software processes digital radiography (DR) images, which are generated from X-ray scans of the human body. It manipulates and combines these images.
- Lack of Specimen Analysis: The software does not analyze any biological specimens. Its input is image data, not biological samples.
Therefore, the device falls under the category of medical imaging software, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The software's intended use is to allow post-capture positioning and joining of individual images to produce an additional composite image. The software is sold only for use on Carestream Health system solutions and is available as an integrated feature within the DirectView software.
Product codes
MQB
Device Description
The DR Long Length Imaging Software is a software component for use on a diagnostic x-ray system utilizing digital radiography (DR) technology. The software option is comprised of image stitching software and a manual stitch editor that allows user adjustment to automatic stitching results. The software allows up to 5 separately acquired DR images to be stitched together to create a "composite" long length image.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
digital radiography (DR)
Anatomical Site
Not Found
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 testing was conducted to verify the design output met the design input requirements and to validate the device conformed to the defined user needs and intended uses. Nonclinical testing was conducted under simulated use conditions. Clinical testing was conducted to evaluate the acceptability of the composite images for diagnostic use. Predefined acceptance criteria were met and demonstrated that the device is as safe, as effective, and performs 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
Traditional 510(k) for DR LLI Software
K130567
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Carestream
JUN 1 1 2013
"510(k) Summary"
585-627-6543
585-323-7643
510(k) Owner Name: 510(k) Owner Address: Carestream Health, Inc. 150 Verona Street Rochester, New York 14608
510(k) Owner Phone: 510(k) Owner Fax:
Contact Person & Info:
Carolyn Wagner Regulatory Affairs Manager, Medical Imaging carolyn.wagner@carestreamhealth.com 585-627-6588
Date Summary Prepared:
June 5, 2013
Device Trade Name: Device Common Name: Classification Name:
Device Class: Device Code: Regulation Number:
Predicate Devices:
DR Long Length Imaging Software DR digital imager Solid state x-ray imager (flat panel/digital imager)
Class II MQB 21 CFR 892.1650
Cedara I-Softview™ (Accustitch"M component) Manufactured by Cedara Software Corp. 510(k) No. - K022881 (October 22, 2002)
Kodak Eclipse Image Processing Software Manufactured by Carestream Health, Inc. 510(k) No. - K060137 (May 16, 2006)
Device Description:
The DR Long Length Imaging Software is a software component for use on a diagnostic x-ray system utilizing digital radiography (DR) technology. The software option is comprised of image stitching software and a manual stitch editor that allows user adjustment to automatic stitching results. The software allows up to 5 separately acquired DR images to be stitched together to create a "composite" long length image.
1
Traditional 510(k) for DR LLI Softwar
K130561
Page 2 of 2
Indications for Use / Intended Use:
The Indications for Use for the device, as described in its labeling, are: "The software's intended use is to allow post-capture positioning and joining of individual images to produce an additional composite image. The software is sold only for use on Carestream Health system solutions and is available as an integrated feature within the DirectView software."
The intended use for this device, as determined by descriptions and the proposed labeling contained in this submission, is similar to the Indications for Use statement provided above. The DR Long Length Imaging software component provides the ability to perform operations related to image manipulation and enhancement of medical images. We believe that the DR Long Length Imaging software and the predicate devices have the same intended use.
The Indications for Use for the subject device is different than the predicate device, but these differences do not alter the intended diagnostic use of the software component. Differences are appropriately characterized as descriptive, and the intended use remains unchanged. Any variation in features or technical specifications have been identified and addressed through testing (described below) to support a substantial equivalence determination.
Comparison of Technological Characteristics:
The DR Long Length Imaging Software has the same technological characteristics as the predicate device, the Cedara I-Softview "Accustitch" component. The DR Long Length Imaging Software is an optional software component that allows a composite image to be formed from up to five separately acquired general radiography images. It is available as an integrated optional feature within the predicate device Kodak Eclipse Image Processing Software (DirectView software). The software device raises no new issues of safety or effectiveness.
Discussion of Testing
Performance testing was conducted to verify the design output met the design input requirements and to validate the device conformed to the defined user needs and intended uses. Nonclinical testing was conducted under simulated use conditions. Clinical testing was conducted to evaluate the acceptability of the composite images for diagnostic use. Predefined acceptance criteria were met and demonstrated that the device is as safe, as effective, and performs as well as the predicate device.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized image of an eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G Silver Spring. MD 20993-0002
June 11. 2013
Carestream Health, Inc. % Ms. Carolyn L. Wagner Regulatory Affairs Manager 150 Verona Street ROCHESTER NY 14608
Re: K130567
Trade/Device Name: DR Long Length Imaging Software Regulation Number: 21 CFR 892.1650 Regulation Name: Solid State X-Ray Imager (Flat Panel/Digital Imager) Regulatory Class: Class II Product Code: MQB Dated: May 7, 2013 Received: May 10, 2013
Dear Ms. Wagner:
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). Yourmay 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 does 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 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
3
Page 2 - Ms. Wagner
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.lda.gov/MedicalDevices/Resourcesfor.You/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/Safetv/ReportalProblem/default.htm for the CDRF/'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/Industrv/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
Indications for Use
510(k) Number (if known): K130567
Device Name: DR Long Length Imaging Software
Indications for Use:
The software's intended use is to allow post-capture positioning and joining of individual images to produce an additional composite image. The software is sold only for use on Carestream Health system solutions and is available as an integrated feature within the DirectView software.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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)
Sm. P)
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health
K130567 510(k)
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