(15 days)
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Not Found
No
The summary does not mention AI, ML, deep learning, or any related terms, and the device description and performance study sections are not available to provide further clues.
No
The device is intended to capture and display radiographic images, which is a diagnostic function, not a therapeutic one. It does not treat or alleviate a medical condition.
Yes
The device is intended to capture radiographic images of human anatomy for display, which is a process used to diagnose medical conditions.
No
The device is described as a "KODAK DirectView DR System Detector," which is a hardware component used to capture radiographic images. The description focuses on the hardware's function and intended use in general projection radiography, not on software functionality as the primary or sole component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The KODAK DirectView DR System Detector is described as a device that "capture[s] for display radiographic images of human anatomy." This is an in vivo imaging process, meaning it involves imaging the body directly, not analyzing samples taken from the body.
- Intended Use: The intended use clearly states it's for "general projection radiographic applications," which is a form of medical imaging.
Therefore, based on the provided information, the KODAK DirectView DR System Detector is a medical imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The KODAK DirectView DR System Detector is intended to capture for display radiographic images of human anatomy. It is intended for use in general projection radiographic applications wherever conventional screen-film systems may be used.
Product codes
MQB
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Radiographic
Anatomical Site
human anatomy
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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) of the USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem that resembles a stylized caduceus, a symbol often associated with healthcare, featuring a staff with a serpent entwined around it.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Christine E. Ehmann Regulatory Affairs Manager Health Imaging Group Eastman Kodak Company 343 State Street ROCHESTER NY 14650
Re: K051483 Trade/Device Name: Kodak DirectView System Detector Regulation Number: 21 CFR 892.1630 Regulation Name: Electrostatic x-ray imaging system . Regulatory Class: II Product Code: MQB Dated: June 3, 2005 Received: June 6, 2005
Dear Ms. Ehmann:
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 the chercoacy to the enactment date of the Medical Device Amendments, or to devices that have been rear 20, 1710, and classes 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 do not roquire approval or a provisions of the Act. The general controls provisions of the Act device, subjoct to the general 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 11 your device 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 statues 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 (QS) (2) CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
JUN 2 1 2005
1
This letter will allow you to begin marketing your device as described in your Section 510(k)
The States of the Caline of a line of a location to tiet aggivelance of your dev This letter will allow you to begin marketing your antial equivalence of your device to a legally
premarket notification. The FDA finding of substantial securedaries and thu premarket notification. The FDA Inding of substantial or 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 Part 801), please If you desire spectific advice for your device of our laboring 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 Also, please note the regulation Childer, "First. "First. And 1990 - 1990 - 1990 - 1990 - 1999 - 1999 - 1999 807.97). You may obtain other geleral monnal and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address 096-2011 07 (21 go v/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Kodak DirectView DR System Detector
Indications for Use Statement
| 510(k) Number (if known): | K051483 |
|---|---|
| Device Name: | Kodak DirectView System Detector |
| Intended Use and Indications for Use: | The KODAK DirectView DR System Detector is intended to capture for display radiographic images of human anatomy. It is intended for use in general projection radiographic applications wherever conventional screen-film systems may be used. |
Concurrence of CDRH, Office of Device Evaluation
Prescription Use (per 21 CFR 801.109) OR
Over-the counter use_
Nancy Brogdon
(Division Sign-Off) (Division Sign-Onlyn-Only Abdol
Division of Reproductive, Abdol
Division of Reproductives Division of Roprocession and Radiological Devices 510(k) Number -