(21 days)
Not Found
No
The summary describes a digital X-ray system that captures images and replaces film/screen systems. There is no mention of AI, ML, or any advanced image processing that would suggest the use of these technologies. The description focuses on the hardware components and their function in capturing digital images.
No
The device is described as providing "digital image capture for conventional film/screen radiographic examinations" and "diagnostic images," indicating its use for diagnosis, not therapy.
Yes
The device is described as providing "digital image capture for conventional film/screen radiographic examinations" and is "intended to replace radiographic film/screen systems in all general purpose diagnostic procedures." It also explicitly states that it "provides diagnostic images for general radiography."
No
The device description explicitly lists hardware components: a Canon X-ray digital camera retrofit kit, a MinXray Portable Source Generator, and Trex proprietary adaptations.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- PDX-2000 Function: The PDX-2000 is an X-ray system. It uses radiation to create images of the inside of the body. This is a form of in vivo (within the living body) diagnostic imaging.
- Intended Use: The intended use clearly states it provides "digital image capture for conventional film/screen radiographic examinations" and is intended to "replace radiographic film/screen systems in all general purpose diagnostic procedures." This describes a standard medical imaging device, not a device that analyzes biological specimens.
Therefore, based on the provided information, the PDX-2000 Portable Digital X-Ray System is a medical imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The PDX-2000 Portable Digital X-ray System provides digital image capture for conventional film/screen radiographic examinations. The device is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures.
Product codes
90 IZL
Device Description
The PDX-2000 Portable Digital X-ray System consists of a Canon X-ray digital camera CXDI-22 retrofit kit, a MinXray Portable Source Generator The PDX-2000 provides diagnostic and Trex proprietary adaptations. images for general radiography with portable table and upright system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
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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)
Not Found
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
§ 892.1720 Mobile x-ray system.
(a)
Identification. A mobile x-ray system is a transportable device system intended to be used to generate and control x-ray for diagnostic procedures. 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
AUG 1 6 2001
510(k) SUMMARY
Prepared:
July 23, 2001
Submitter:
TREX Enterprises Corporation 10455 Pacific Center Court San Diego, CA 92121-4339 Phone: 858-646-5300 Fax: 858-646-5301
Contact Person:
Peter J. Martin, Ph.D. Manager, Digital Medicine Group Phone: 808-875-2616 Fax: 808-875-2611
Establishment Registration & Device Listing:
Submitted - FDA Response Pending
PDX-2000 Portable Digital X-ray System
Device Trade Name:
Various Models of X-ray Systems Common Name:
Class II - Radiology Panel Classification:
90 IZL
Mobile X-ray system. (per 21 CFR section 892.1720) Classification Name:
Product Code:
Predicate Devices:
MinXray HF100H Portable X-ray Generator Manufactured by MinXray Inc. 3611 Commercial Avenue Northbrook, IL 60062-1822 90 IZL - K973712 Decision Date: 12-12-97
Canon CXDI-11 X-ray Digital Camera & Canon CXDI-22 X-rav Digital Camera Manufactured by Canon U.S.A. Inc. One Canon Plaza Lake Success, NY 11042 90 MQB - K 981556 & K992547 Decision Date: 10-13-99
Description of Device:
The PDX-2000 Portable Digital X-ray System consists of a Canon X-ray digital camera CXDI-22 retrofit kit, a MinXray Portable Source Generator The PDX-2000 provides diagnostic and Trex proprietary adaptations. images for general radiography with portable table and upright system.
Intended Use of Device:
The PDX-2000 Portable Digital X-ray System provides digital image capture The device is for conventional film/screen radiographic examinations. intended to replace radiographic film/screen systems in all general purpose diagnostic procedures.
| Table of Comparison: | TREX PDX-2000 | PREDICATE DEVICE |
|---|---|---|
| Canon CXDI-11 X-ray Digital Camera | Same | |
| Canon CXDI-22 X-ray Digital Camera | Same | |
| MinXray HF100H Portable X-ray Generator | Same |
1
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 6 2001
Peter J. Martin, Ph.D. Manager, Digital Medicine Group Trex Enterprises Corporation 10455 Pacific Center Court SAN DIEGO CA 92121-4339
Re: K012379
PDX 2000 Portable Digital X-Ray System Dated: July 23, 2001 Received: July 26, 2001 Regulatory Class: II ----21 CFR 892.1720/Procode: 90 IZL
Dear Dr. Martin:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4639. 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 807.97). 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 Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Page of
510(k) Number (if known): Not Yet Assigned
Device Name: PDX-2000
Indications for Use:
The PDX-2000 Portable Digital X-Ray System provides digital image capture for conventional film/screen radiographic examinations. The device is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
V Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use (Optional Format 1-2-96)
Nancy C burden
(Division Sign-Off), Division of Reproductive, Abdominal, ENT And Radiological Devices
510(k) Number K012379