(58 days)
Not Found
No
The summary describes a digital imaging system using standard components and image processing, with no mention of AI, ML, or related concepts.
No
This device is an imaging system used to generate radiographic images for diagnostic purposes, not for therapeutic treatment.
No
This device generates radiographic images, which are used by qualified medical personnel for diagnostic purposes, but the device itself does not perform diagnosis. It is an image acquisition system.
No
The device description explicitly lists multiple hardware components including a flat panel imager, computer, road runner card, trigger board, and power supply, in addition to the imaging software.
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).
- Device Function: The PaxScan 4030 Medical Digital Imaging System is used to generate radiographic images of human anatomy using X-rays. This is an imaging device that works on the body, not with specimens taken from the body.
- Intended Use: The intended use clearly states it's for generating radiographic images of human anatomy and replacing film/screen or computed radiography. This aligns with diagnostic imaging, not in vitro testing.
Therefore, based on the provided information, the PaxScan 4030 Medical Digital Imaging System is a diagnostic imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The PaxScan 4030 Medical Digital Imaging System is intended for use in generating radiographic images of human anatomy. It is intended to replace film/screen or computed radiography in extremity and general-purpose procedures appropriate to the input field of view. This device is intended for use by qualified medical personnel trained in radiology
Product codes
90MQB
Device Description
The PaxScan 4030 Medical Digital Imaging System is composed of an amorphous silicon flat planel imager, Pentium based computer, road runner card, trigger board, imaging software and a power supply. The digital imager uses a large-area amorphous silicon sensor array with a gadolinium oxysulfide scintillator. The 40 x 30 cm panel will display high quality images in approximately five seconds over a wide range of dose settings.
Mentions image processing
Yes
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 trained in radiology
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)
K982795, K981556, K993861, K992794
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
FEB 1 2 2003
510(k) Summary
K024/47
The following information is provided following the format of 21 CFR 807.92 for the PaxScan 4030 Medical Digital Imaging System.
| 1. Submitter: |
|---|
| Varian Medical Systems |
| 3100 Hansen Way M/S H055 |
| Palo Alto, CA 94304-1129 |
| Contact Name: Linda S. Nash |
| Corporate Director, Regulatory Affairs and |
| Quality Assurance |
| Phone: (650) 424-6990 |
| Fax: (650) 855-7364 |
| Email: linda.nash@varian.com |
| Date: November 21, 2002 |
- Device Name:
| Classification Name: | Solid State X-ray Imaging Device |
|---|---|
| Common/Usual Name: | Flat Panel Digital Imager |
| Proprietary Name: | PaxScan 4030 Medical Digital Imaging System |
- Equivalent Devices:
| Proprietary Names: | Philips Bucky
Vision | Canon X-Ray
Digital Camera | Fugi CR
System | Infimed
Stringray DR |
|--------------------|-------------------------------|-------------------------------|-------------------|-------------------------|
| 510(K) Numbers: | K982795 | K981556 | K993861 | K992794 |
| Common Name: | Solid State X-Ray Imager | | | |
| Regulatory Class: | Class II, 21 CFR 892.6150/630 | | | |
| Panel: | Radiology | | | |
| Product Code: | 90MQB | | | |
- Device Description:
The PaxScan 4030 Medical Digital Imaging System is composed of an amorphous silicon flat planel imager, Pentium based computer, road runner card, trigger board, imaging software and a power supply. The digital imager uses a large-area amorphous silicon sensor array with a gadolinium oxysulfide scintillator. The 40 x 30 cm panel will display high quality images in approximately five seconds over a wide range of dose settings.
- Statement of Intended Use:
The PaxScan 4030 Medical Digital Imaging System is intended for use in generating radiographic images of human anatomy. It is intended to replace film/screen or computed radiography in extremity and general-purpose procedures appropriate to the input field of view.
- Comparison to substantially equivalent devices: The PaxScan 4030 is substantially equivalent to:
1
Philips Bucky Vision Canon X-Ray Digital Camera Fuji CR System Infimed Stingray DR
510(k) No. K982795 510(k) No. K981556 510(k) No. K993861 510(k) No. K992794
The following comparison chart depicts the comparison characteristics.
| | Varian 4030R
Flat Panel Imager | Philips Bucky
Vision | Canon X-Ray
Digital Camera | Fuji CR System | InfiMed Stingray DR |
|-------------------------------|------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| 510(k)
Number | N/A | K982795 | K981556 | K993861 | K992794 |
| Flat Panel
Producer | Varian Medical
Systems | Trixell | Canon | Fuji | Trixell |
| Detector
Material | Amorphous Silicon
Sensor Array with
Gadolinium
Oxysulfide
Scintillator | Amorphous Silicon
Sensor Array with
Gadolinium
Oxysulfide
Scintillator | Scintillator over
Amorphous
Silicon Sensor
with thin film
Transistor Array | Photostimulable
phosphor imaging
plate europium
activated barium
flurohalide
compounds in
crystal form | Amorphous Silicon
Sensor Array with
Gadolinium
Oxysulfide Scintillator |
| Dimensions | 16" x 11.5" | 17" x 17" | 17" x 17" | 17" x 17" | 17" x 17" |
| Pixel Size | 127 x 127 microns | 143 x 143 microns | 160 x 160
microns | Standard mode
200 microns ;
high density
mode 100 microns | 143 x143 microns |
| Detector
Element
Matrix | 2232 x 3200 | 2981 x3021 | 2688 x 2688 | 2140 x 2140 | 2981 x 3021 |
| Dynamic
Range | 12 bits | 14 bits | 14 bits | 10 bits | 14 bits |
| Spatial
Resolution | 3.94 lp/mm | 3.5 lp/mm | 3.1 lp/mm | 4.0+ lp/mm | 3.5 lp/mm |
| External
Connectivity | DICOM 3.0
Compatible | DICOM 3.0
Compatible | DICOM 3.0
Compatible | DICOM 3.0
Compatible | DICOM 3.0
Compatible |
| Operator
Console | Graphical User
Interface Based
Pentium PC | Graphical User
Interface Based
Sun Ultra SPARC | Graphical User
Interface Based
Pentium PC | Graphical User
Interface Based
Pentium PC | Graphical User
Interface Based
Pentium PC |
| Image
Processor | Hard Drive | Hard Drive | Hard Drive | Hard Drive | Hard Drive |
| Image Storage | Hard Drive | Hard Drive | Hard Drive | Hard Drive | Hard Drive |
| Operating
System | Windows NT,
2000 | UNIX | Windows NT | Windows 98, NT | Windows NT |
| Image
Processing
Time | 5 Seconds per
Image | 8 Seconds per Image | 30 Seconds per
Image | 3-5 Minutes per
Image | 8 Seconds per Image |
| Power
Requirements | 100-240 VAC
50/60 Hz | 230 V 50/60 Hz | 110/120 V &
230/240 V 50/60
Hz | 200-240 V 50/60
Hz
100-120 V 50/60
Hz | 110/120 V & 230/240
V 50/60 Hz |
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 2 2003
Ms. Linda S. Nash Corporate Director, Regulatory Affairs and Quality Assurance Varian Medical Systems, Inc. 3100 Hansen Way PALO ALTO CA 94304-1038
Re: K024147 Trade/Device Name: PaxScan 4030 Medical Digital Imaging System Regulation Number: 21 CFR 892.1630 Regulation Name: Electrostatic x-ray imaging system Regulatory Class: II
Product Code: 90 MQB Dated: November 20, 2002 Received: December 16, 2002
Dear Ms. Nash:
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.
3
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
Enclosure
Page 2
4
Statement of Indications for Use
510(k) Number (if known): K024147
| Device Name: | PaxScan 4030 Medical Digital Imaging System |
|---|---|
| Indications For Use: | The PaxScan 4030 Medical Digital Imaging System is intended for use in generating radiographic images of human anatomy. It is intended to replace film/screen or computed radiography in extremity and general-purpose procedures appropriate to the input field of view. |
| This device is intended for use by qualified medical personnel trained in radiology | |
| Contraindications for Use: | The use of the PaxScan 4030 Medical Digital Imaging System are contraindicated when, in the judgment of the physician, procedures would be contrary to the best interests of the patient. |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use L (Per 21 CFR 801.109)
OR
Over-The-Counter Use (Optional Format 1-2-96)
Naruse Brogdon
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number _