(34 days)
K 894643
K 894643
No
The document describes a standard mobile x-ray system with no mention of AI or ML capabilities in its intended use, device description, or performance studies.
No
The device is described as an x-ray system "to x-ray body parts of patients to create images for medical diagnostic purposes," indicating it is used for diagnosis, not treatment.
Yes
The intended use states that the device is used to "create images for medical diagnostic purposes," directly indicating its role in diagnosis.
No
The device description clearly outlines numerous hardware components, including a motor-driven system, battery, wheels, x-ray generator, x-ray tank, collimator, and optional hardware like a pre-filter and remote control. This is not a software-only device.
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, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Practix Convenio function: The Practix Convenio is an X-ray system. It works by generating X-rays that pass through the patient's body to create images. This is a form of in vivo (within the living body) imaging.
- Intended Use: The intended use clearly states it is "to x-ray body parts of patients to create images for medical diagnostic purposes." This describes an imaging procedure performed directly on the patient, not testing of a specimen.
Therefore, based on the provided information, the Practix Convenio is a medical imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Practix Convenio is a mains independent motor driven mobile x-ray system, to x-ray body parts of patients to create images for medical diagnostic purposes. The Practix Convenio is intended to x-ray in rooms for medical use.
Product codes
90 IZL
Device Description
The Practix Convenio is a motor driven battery supplied mobile x-ray unit to be operated indoors only. The system contains: Battery cluster including battery charger, two passive and two motor driven wheels, 20 kHz converter x-ray generator excluding the high voltage unit, 360° turn able column and a telescope arm to carry x-ray unit, x-ray tank (x-ray tube housing assembly and high voltage unit), collimator (beam limiting device) and a drawer to carry x-ray film cassettes and an anti scatter grid. The following components are optional: Removable pre filter, dose area product measurement, automatic exposure control and an infrared remote control.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray
Anatomical Site
body parts of patients
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical 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)
K 894643
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
000 4 - 2004
510(k) Summary
In accordance with the requirements of 21 CFR 807.92 27 Auqust 2004
1. Contact person
Lynn Harmer Philips Medical Systems 22100 Bothell Everett Highway Bothell, Washington 98021-8431 Phone: (425) 487-7312 Fax: (425) 487-8666
2. Device name and classification
Trade name: Practix Convenio Classification name: Mobile x-ray system Classification panel: Radiology devices Requlatory status: Class II Device classification req. nr .: 21CFR 892.1720
3. Predicate device
Trade name: RT-125 ROUGH TERRAIN MOBILE X-RAY UNIT (also known as PMX 2000) Manufacturer: Lorad 510(k) Number: K 894643
4. Description
The Practix Convenio is a motor driven battery supplied mobile x-ray unit to be operated indoors only. The system contains: Battery cluster including battery charger, two passive and two motor driven wheels, 20 kHz converter x-ray generator excluding the high voltage unit, 360° turn able column and a telescope arm to carry x-ray unit, x-ray tank (x-ray tube housing assembly and high voltage unit), collimator (beam limiting device) and a drawer to carry x-ray film cassettes and an anti scatter grid. The following components are optional: Removable pre filter, dose area product measurement, automatic exposure control and an infrared remote control.
5. Intended Use
The Practix Convenio is a mains independent motor driven mobile x-ray system, to x-ray body parts of patients to create images for medical diagnostic purposes. The Practix Convenio is intended to x-ray in rooms for medical use.
6. Comparison to predicate device
The Practix Convenio does not introduce any new indications for use, nor does the use of the device result in any new potential hazard. Philips Medical Systems considers the Practix Convenio to be substantially equivalent with the predicate device.
1
Image /page/1/Picture/0 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or other bird.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Lynn Harmer Manager, Regulatory Submissions Philips Medical Systems North America 22100 Bothell Evert Highway BOTHELL WA 98021-8431
Re: K042368
OCT 4 - 2004
Trade/Device Name: Practix Convenio Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: II Product Code: 90 IZL Dated: August 27, 2004 Received: August 31, 2004
Dear Ms. Harmer:
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 (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 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/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
Enclosure
3
Indications for Use
510(k) Number (if known):
K$\phi$42368
Device Name: Practix Convenio
Indications For Use:
The Practix Convenio is a mains independent motor driven mobile x-ray system, to x-ray body parts of patients to create images for medical diagnostic purposes. The Practix Convenio is intended to x-ray in rooms for medical use.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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)
Dorind A. Lymm
(Division Sign-Off) Division of Reproductive, Abdomina and Radiological Devices 510(k) Number