(29 days)
No
The summary describes a standard computer radiography (CR) system for digital radiography and long length imaging. There is no mention of AI, ML, or advanced image processing techniques that would typically indicate the presence of such technology. The description focuses on the hardware and basic software interface for image acquisition and export.
No.
The device is described as a digital radiography system for diagnostic imaging, which falls under diagnostic devices, not therapeutic. Its intended use is for acquiring images for diagnosis, not for treating diseases or conditions.
Yes
The "Intended Use / Indications for Use" states that the device is intended for "standard radiographic diagnostic images," directly indicating its role in diagnosis.
No
The device description explicitly states it includes a CR acquisition scanner, a Man Machine Interface panel, and a CR scanner, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is for "digital radiography using a phosphor storage screen for standard radiographic diagnostic images" and "Long Length Imaging examinations of long areas of anatomy such as the leg and spine." This describes an imaging device used to capture images of the body, not a device used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information about a physiological or pathological state.
- Device Description: The description details a "Computer Radiography (CR) acquisition scanner" and a "CR cassette." These are components of a medical imaging system, not an IVD.
- Input Imaging Modality: "digital radiography using a phosphor storage screen" is an imaging modality, not a method for analyzing biological specimens.
IVD devices are specifically designed to be used in vitro (outside the living body) for the examination of specimens derived from the human body. This device operates in vivo (within the living body) by capturing images of the patient's anatomy.
N/A
Intended Use / Indications for Use
The Point-of-Care is intended for digital radiography using a phosphor storage screen for standard radiographic diagnostic images.
The LLI is indicated for Long Length Imaging examinations of long areas of anatomy such as the leg and spine.
Product codes (comma separated list FDA assigned to the subject device)
MOB, MQB
Device Description
Point of care including LLI is a Computer Radiography (CR) acquisition scanner, which includes mechanical and software interface to the LLI cassette. The device is constructed from a Man Machine Interface panel, a CR scanner and infrastructure, which enables connection to external applications, i.e. to import command messages, to export images and provide status messages. The LLI is a CR cassette, which is used for Long Length Imaging X Ray examinations of long areas of anatomy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
digital radiography, X Ray
Anatomical Site
leg and spine, long areas of 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)
The device has been designed, verified and validated in compliance with the 21CFR 820.30 regulations. Bench and clinical data demonstrate that the device meets the required specifications. No adverse affects have been detected.
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.
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.
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.
0
Image /page/0/Picture/0 description: The image shows a handwritten string of alphanumeric characters. The string appears to be "K073670". The characters are written in black ink on a white background. The handwriting is somewhat stylized, with some characters connected and others distinct.
510(k) Summary of Safety and Effectiveness (in accordance to 21 CFR 807.87(b)
Device Name
Proprietary Device Name: Point of care including LLI
Establishment Name and Registration Number of Submitter
Name: OREX Computed Radiography Ltd Registration: 3003343596 Owner: CARESTREAM HEALTH, INC Submission contact: Dan Laor
Device Classification
Device Code: MOB CFR Section: 892.1650 Name: CR- Computerized radiography Classification: Class II Product Review Advisory Committee: Radiology
Reason for 510(k) Submission
Special 510(k) Submission
Identification of Legally Marketed predicate Devices
- Kodak unmodified predicate device: (K021829) Kodak DirectView CR ii Long Length
Device Description
Point of care including LLI is a Computer Radiography (CR) acquisition scanner, which includes mechanical and software interface to the LLI cassette. The device is constructed from a Man Machine Interface panel, a CR scanner and infrastructure, which enables connection to external applications, i.e. to import command messages, to export images and provide status messages. The LLI is a CR cassette, which is used for Long Length Imaging X Ray examinations of long areas of anatomy.
Indications for use
The Point-of-Care is intended for digital radiography using a phosphor storage screen for standard radiographic diagnostic images.
The LLI is indicated for Long Length Imaging examinations of long areas of anatomy such as the leg and spine.
Safety & Effectiveness
The device has been designed, verified and validated in compliance with the 21CFR 820.30 regulations. Bench and clinical data demonstrate that the device meets the required specifications. No adverse affects have been detected.
Substantial Equivalency
Orex opines that the Point of Care including the LLI is substantially equivalent in terms of safety and effectiveness to the predicate devices.
JAN 25 2008
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract eagle or bird in flight, composed of three curved lines.
1 25 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Moshe Shenhav Director, QA & Regulatory Affairs OREX Computed Radiography Ltd. Star Bldg. Yokneam, P.O. Box 505 Yokneam 20692 ISRAEL
K073670 Re:
Trade/Device Name: Point of Care including LLI Regulation Number: 21 CFR §892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: MQB Dated: December 6, 2007 Received: December 27, 2007
Dear Mr. Shenhav:
We have reviewed your Section 510(k) premarket notification of intent to market the devicereferenced 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. Iisting 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 (PMA), 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.
2
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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) 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" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrb/industry/support/index.html.
Sincerely yours.
Nancy Cbrogdon
Nancy C. Brogdon Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
K073670 510(k) Number (if known):
Point of Care including LLI Device Name:
Indications for Use: The Point-of-Care is intended for digital radiography using a phosphor storage screen for standard radiographic diagnostic images.
The LLI is indicated for Long Length Imaging examinations of long areas of anatomy such as the leg and spine.
Prescription Use: YES (Part 21 CFR 801 Subpart D)
AND/OR
Over-the-Counter Use: NO (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Concurrence of CDRL
(Division Sign-Off)
Division of Reproductive, Abdominal and Radiological Devices 510(k) Number _
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