(56 days)
Not Found
Not Found
No
The summary describes a laser scanner for reading imaging plates and mentions image processing software, but there is no mention of AI, ML, or related concepts.
No
The device is a laser scanner for reading imaging plates and producing digital images for projection radiography. It is not described as directly treating or alleviating a medical condition.
No
The device is described as a "compact laser scanner" that reads images from a storage phosphor imaging plate. While it produces a digital image for "projection radiography applications," there is no mention of analysis, interpretation, or diagnosis of medical conditions. Its function is image acquisition, not diagnosis.
No
The device description explicitly mentions "compact laser scanners" and "storage phosphor imaging plate," which are hardware components. The software mentioned is for image processing, but it is part of a system that includes hardware.
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 "projection radiography applications." This involves imaging the internal structures of the body using X-rays and a storage phosphor plate. This is a diagnostic imaging process performed on a living patient, not a test performed on a sample taken from the body (which is the definition of an in vitro diagnostic).
- Device Description (Implied): While the description is "Not Found," the intended use and input modality (storage phosphor imaging plate) strongly indicate a medical imaging device used for capturing and digitizing radiographic images.
- No Mention of In Vitro Testing: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or performing tests outside of the body.
Therefore, the CR Systems described are medical imaging devices used for diagnostic purposes in vivo (within the living body), not in vitro (outside the living body).
N/A
Intended Use / Indications for Use
The CR Systems are compact laser scanners capable of reading the latent image formed on a storage phosphor imaging plate and producing a digital image for projection radiography applications. This excludes mammography applications for the Kodak Ektascan Storage Phosphor Reader and the Kodak Eclipse Image Processing Software in the United States.
Product codes
MOB
Device Description
Kodak Eclipse Image Processing Software
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal is circular and contains the department's name around the perimeter. In the center of the seal is an abstract image of an eagle, which is the symbol of the United States. The eagle is depicted in a stylized manner, with its wings spread and its head turned to the left.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 6 2005
Ms. Linda Stewart Regulatory Affairs Director Eastman Kodak Company Health Group 343 State Street ROCHESTER NY 14650
Re: K060137
Trade/Device Name: Kodak Eclipse Image processing software Regulation Number: 21 CFR 892.1630 Regulation Name: Solid state x-ray imaging system Regulatory Class: II Product Code: MOB Dated: February 21, 2006 Received: February 22, 2006
Dear Ms. Stewart:
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 either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the clectronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
1
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.
ff you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Nancy C. Brigdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Anachment 3 Special 510(k): Eastman Kodak Company
Indications for Use
510(k) Number (if known): K060137
Device Name: Kodak Eclipse Image Processing Software
Indications for Use:
The CR Systems are compact laser scanners capable of reading the latent image formed on a storage phosphor imaging plate and producing a digital image for projection radiography applications. This excludes mammography applications for the Kodak Ektascan Storage Phosphor Reader and the Kodak Eclipse Image Processing Software in the United States.
Over-The-Counter Use Prescription Use X Prescription Ose _____________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel br. beyram
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________
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Document # 4H0521 Rev 1.0