(42 days)
No
The description focuses on hardware (cassette, screen, reader) and basic image processing software for display, enhancement, and storage. There is no mention of AI, ML, or related concepts like algorithms for image analysis or decision support.
No.
The device is indicated for "portal imaging (Radiation Therapy Quality Control)", meaning it is used for quality control of radiation therapy, not for administering therapy itself.
No
The device is an accessory (PoRT Cassette) for a digital imaging system (PcCR Digital Imaging Device) used for portal imaging in radiation therapy. Its intended use is for "Radiation Therapy Quality Control," which involves imaging to verify the accurate targeting of radiation rather than to diagnose a medical condition. While it captures images, its purpose is for quality assurance and verification of treatment delivery, not for diagnosing disease or medical conditions.
No
The device description clearly states that the PoRT Cassette is a physical accessory (a reusable phosphor screen) and part of a larger system that includes hardware components like an image reader/digitizer. While there is a software upgrade mentioned, the device itself is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "portal imaging (Radiation Therapy Quality Control)". This is a diagnostic imaging application used to verify the accuracy of radiation therapy delivery, not to diagnose a disease or condition based on in vitro examination of specimens.
- Device Description: The device is a digital radiography system using phosphor storage screens to capture X-ray images. This is a standard medical imaging technology, not an in vitro diagnostic method.
- No Mention of In Vitro Testing: The description focuses on capturing and processing radiographic images of the patient's body, not on analyzing biological samples (like blood, urine, tissue, etc.) outside of the body.
IVD devices are specifically designed to perform tests on specimens taken from the human body to provide information for the diagnosis, treatment, or prevention of disease. This device's function is clearly related to in vivo imaging for quality control in radiation therapy.
N/A
Intended Use / Indications for Use
The PoRT Cassette is an accessory to the PcCR Digital Imaging Device and is indicated for portal imaging (Radiation Therapy Quality Control).
Product codes
IXK
Device Description
The PoRT Cassette is an optional cassette to be used with the PcCR Digital Imaging Devices for portal imaging. The PcCR Digital Imaging Devices are filmless systems intended for digital radiography using a phosphor storage screen which were cleared under K003256. The PcCR Digital Imaging device enables the clinician to scan or import images for display, review, or storage in a database. The PcCR device consists of reusable phosphor storage screens for recording radiographic images, an image reader/digitizer, and software for displaying, enhancing, and storing radiographs using a user-provided personal computer. The PoRT Cassette is optional cassette to be used with the PcCR System and is also a reusable phosphor screen. It is offered in 14" x 17" size. Other than the addition of the PoRT Cassette and a software upgrade, the PcCR Digital Imaging Device is identical to that described in K003256.
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
Clinician
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
Bench testing and clinical validation demonstrate that the PoRT Cassette performs according to specifications.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1630 Electrostatic x-ray imaging system.
(a)
Identification. An electrostatic x-ray imaging system is a device intended for medical purposes that uses an electrostatic field across a semiconductive plate, a gas-filled chamber, or other similar device to convert a pattern of x-radiation into an electrostatic image and, subsequently, into a visible image. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
OCT = 9 2003
510(k) Summary
for
PcCR Digital Imaging Devices for X-Ray Systems
DATE SUMMARY PREPARED 1.
August 26, 2003
SUBMITTER'S NAME AND ADDRESS 2.
Orex Computed Radiography Ltd. Yoqneam "Star" Bldg. NESHED 36603 NESHER 36603 : 2 ISRAEL
3. CONTACT PERSON
Moshe Shenhav Telephone: 011 972 4 959 1331 Facsimile: 011 972 4 959 1262
4. DEVICE NAME
Trade/Proprietary Name: PoRT Cassette Accessory to Electrostatic X-ray imaging system Common Name: Accessory to Electrostatic X-ray imaging system Classification Name:
PREDICATE DEVICES ડ.
The legally marketed device to which equivalence is being claimed is: Kodak EC-L Cassette/EC-V Verification System for Portal Imaging (K960834)
6. DEVICE DESCRIPTION
The PoRT Cassette is an optional cassette to be used with the PcCR Digital Imaging Devices for portal imaging. The PcCR Digital Imaging Devices are filmless systems intended for digital radiography using a phosphor storage screen which were cleared under K003256. The PcCR Digital Imaging device enables the clinician to scan or import images for display, review, or storage in a database. The PcCR device consists of reusable phosphor storage screens for recording radiographic images, an
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image reader/digitizer, and software for displaying, enhancing, and storing radiographs using a user-provided personal computer. The PoRT Cassette is optional cassette to be used with the PcCR System and is also a reusable phosphor screen. It is offered in 14" x 17" size. Other than the addition of the PoRT Cassette and a software upgrade, the PcCR Digital Imaging Device is identical to that described in K003256.
7. INTENDED USE
The PoRT Cassette is an accessory to the PcCR Digital Imaging Device and is indicated for portal imaging (Radiation Therapy Quality Control).
8. BASIS FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE
Orex Computed Radiography Ltd. bases the claim of equivalence to cited predicate devices upon similarities in intended use, technological characteristics, and operational characteristics. Bench testing and clinical validation demonstrate that the PoRT Cassette performs according to specifications.
2
Image /page/2/Picture/1 description: The image shows a circular seal or logo. The seal features the symbol of the Department of Health & Human Services (HHS) in the center, which is a stylized eagle with three lines representing the agency's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the perimeter of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT - 9 2003
Orex Computed Radiography, Ltd. % Ms. Mary McNamara-Cullinane, RAC Staff Consultant Medical Device Consultants, Inc. 49 Plain Street NORTH ATTLEBORO MA 02760
Re: K032654 Trade/Device Name: PoRT Cassette
Regulation Number: 21 CFR 892.1630 Regulation Name: Electrostatic x-ray imaging system Regulatory Class: II Product Code: 90 IXK Dated: August 26, 2003 Received: August 28, 2003
Dear Ms. McNamara-Cullinane:
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 (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); 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.
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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 Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:
| 8xx. 1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
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510(k) Number (if known):
Device Name: PoRT Cassette
Indications for Use:
The PoRT Cassette is an accessory to the PcCR Digital Imaging Device and is indicated for portal imaging (Radiation Therapy Quality Control).
(PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancyc hogdon
(Division Sign-Off)
Division of Reproductive, A and Radiological Devices 510(k) Number
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
Orex Computed Radiography Ltd. 510(k) PcCR Digital Imaging Devices
August 26, 2003