(74 days)
K024147, K904519A
Not Found
No
The document describes a standard digital X-ray imaging system with image viewing software and does not mention any AI or ML capabilities.
No
The device is described as an imaging system used to generate radiographic images for diagnostic purposes, not for treating a disease or condition.
Yes
Explanation: The device is intended for generating radiographic images of human anatomy, which is a diagnostic procedure.
No
The device description explicitly states that the system consists of two components: an amorphous silicon digital x-ray imager (hardware) and software for viewing images. This is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to generate radiographic images of human anatomy using X-rays. This is a diagnostic imaging procedure performed directly on the patient, not on a sample taken from the patient.
- Device Description: The device is a digital X-ray imaging system. It captures images of the internal structure of the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a physiological state, health, or disease. This device does not interact with or analyze such specimens.
Therefore, the PortaVision PVMed DDR 2520 Digital Imaging System falls under the category of medical imaging devices, not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
The PortaVision PVMed DDR 2520 Digital Imaging System is intended for use in generating radiographic images of human anatomy. (The system is not intended to be use for mammography). It is intended to replace film/screen or computed radiography in extremity and general-purpose procedures appropriate to the input field of view. This imager is intended for incorporation into a complete x-ray system by a qualified equipment manufacturer. This device is intended for use by qualified medical personnel and is contraindicated when, in the judgment of the physician, procedures would be contrary to the best interest of the patient.
Product codes (comma separated list FDA assigned to the subject device)
IXK
Device Description
The PortaVision PVMed DDR 2520 Digital Imaging System consists of two components, an amorphous silicon digital x-ray imager and software for viewing the captured images on a Windows-based computer. The digital imager is composed of an amorphous silicon flat panel imager which uses a large-area amorphous silicon sensor array with a gadolinium oxysulfide scintillator. The PVMed DDR 2520 Digital Imaging System will display high quality images in less that 5 seconds over a wide range of X-Ray dose settings. The System is not intended to be use for mammography.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-Ray
Anatomical Site
human anatomy
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified medical personnel
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): 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.
K024147, K904519A
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.
Not Found
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
§ 892.1630 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
SECTION 5. 510(K) SUMMARY
| Submission
Correspondent: | Emergo Group, Inc.
1101 S. Capital of Texas Hwy, Suite F254
Austin, Texas, USA | | |
|---------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------|--------------|
| | Phone: | 512.327.9997 | |
| | Fax: | 512.327.9998 | |
| | Email: | igordon@emergogroup.com | |
| | Contact: | Ian Gordon
Sr. Vice President | DEC 1 1 2007 |
| Submission Sponsor: | PortaVision, LLC
5401 Cocos Plumosas Dr.
Kenner, LA 70065 | | |
| | Phone: | (504) 883-4133 | |
| | Email: | tancar@angiovision.com | |
| | Contact: | Terry Ancar
President | |
| Date summary prepared: | April 10, 2007 | | |
| Device trade name: | The PortaVision Medical Digital Imaging System | | |
| Device common name: | Solid State X-ray Imager (Flat Panel/Digital Imager) | | |
| Device classification name: | Electrostatic x-ray imaging system (solid-state x-ray imaging system x-ray
system).
IXK at 21 CFR Part 892.1630 | | |
| Legally marketed devices
to which the device is
substantially equivalent: | K024147
Paxscan 4030 Medical Digital Imaging Systems
Varian Medial Systems, Inc. | K904519A
ADC-70
Agfa Medical Systems | |
| Description of the device: | The PortaVision PVMed DDR 2520 Digital Imaging System consists of two
components, an amorphous silicon digital x-ray imager and software for
viewing the captured images on a Windows-based computer.
The digital imager is composed of an amorphous silicon flat panel imager
which uses a large-area amorphous silicon sensor array with a gadolinium
oxysulfide scintillator. The PVMed DDR 2520 Digital Imaging System will
display high quality images in less that 5 seconds over a wide range of X-
Ray dose settings. The System is not intended to be use for
mammography. | | |
.
1
:
| Intended use of the device: | The PortaVision PVMed DDR 2520 Digital Imaging System is intended for
use in generating radiographic images of human anatomy. The system is
not intended to be used for mammography. It is intended to replace
film/screen or computed radiography in extremity and general-purpose
procedures appropriate to the input field of view. This imager is intended
for incorporation into a complete x-ray system by a qualified equipment
manufacturer. This device is intended for use by qualified medical
personnel and is contraindicated when, in the judgment of the physician,
procedures would be contrary to the best interest of the patient |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological
characteristics: | The technological characteristics between the predicate and proposed
devices are identical. There is no difference in fundamental scientific
technology. The only difference is the size. The proposed device is
smaller than the predicate device. |
| Conclusions: | By definition, a device is substantially equivalent when the device has the
same intended use and the same technological characteristics as the
predicate device.
There are no significant differences between the PortaVision PVMed DDR
2520 Digital Imaging System the predicate devices and therefore, the
PortaVision PVMed DDR 2520 Digital Imaging System does not raise any
questions regarding safety and effectiveness.
The PortaVision PVMed DDR 2520 Digital Imaging System, as designed,
is as safe and effective as the predicate device, and the device is
determined to be substantially equivalent to the referenced predicate
device currently on the market. |
:
:
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract design of three stylized human profiles facing to the right, stacked on top of each other.
DEC 1 1 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
PortaVision Medical % Mr. Daniel W. Lehtonen Senior Staff Engineer-Medical Devices Intertek Testing Services 2307 E. Aurora Rd., Unit B7 TWINSBURG OH 44087
Re: K072766
Trade/Device Name: PortaVision PVMed DDR 2520 Digital Imaging System Regulation Number: 21 CFR 892.1630 Regulation Name: Electrostatic x-ray imaging system Regulatory Class: II Product Code: IXK Dated: November 21, 2007 Received: November 26, 2007
Dear Mr. Lehtonen:
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 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.
3
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 vour 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/cdrh/industry/support/index.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
4
SECTION 4. INDICATIONS FOR USE STATEMENT
| 510(k) Number: | |
|---|---|
| Device Name: | PortaVision PVMed DDR 2520 Digital Imaging System |
| Indications for Use: | The PortaVision PVMed DDR 2520 Digital Imaging System is intended for use in generating radiographic images of human anatomy. (The system is not intended to be use for mammography). It is intended to replace film/screen or computed radiography in extremity and general-purpose procedures appropriate to the input field of view. This imager is intended for incorporation into a complete x-ray system by a qualified equipment manufacturer. This device is intended for use by qualified medical personnel and is contraindicated when, in the judgment of the physician, procedures would be contrary to the best interest of the patient. |
Prescription Use _ × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Tzu M. Nhan
(Division Division of Reproductive, Abdominal and Radiological Devic 510(k) Number