(48 days)
Not Found
No
The document describes a standard X-ray detector and its components. There is no mention of AI, ML, or advanced image processing that would suggest the use of such technologies. The performance studies focus on standard imaging metrics like BE and MTF, and the comparison to the predicate device is based on design and construction similarities.
No
The "Intended Use" states that the device is "indicated for use in generating radiographic images of human anatomy for diagnostic X-ray procedures." This indicates a diagnostic purpose, not a therapeutic one.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "indicated for use in generating radiographic images of human anatomy for diagnostic X-ray procedures."
No
The device description lists multiple hardware components (detector, cables, interface unit, etc.), indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "generating radiographic images of human anatomy for diagnostic X-ray procedures." This describes an imaging device used in vivo (within the living body) to produce images for diagnosis.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. This device does not perform tests on such samples.
- Device Description: The components listed are consistent with an X-ray detector and its associated hardware for capturing and transmitting radiographic images.
- Lack of IVD-related information: There is no mention of analyzing biological samples, performing laboratory tests, or any other activities typically associated with IVDs.
Therefore, the XRpad2 3025 HWC-M is a radiographic imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The XRpad2 3025 HWC-M, when used with a radiographic imaging system, is indicated for use in generating radiographic images of human anatomy for diagnostic X-ray procedures, wherever conventional screen-film (SF), digital radiography (DR), or computed radiography (CR) systems may be used. It is not intended for mammonfions.
Product codes (comma separated list FDA assigned to the subject device)
MQB
Device Description
standard X-ray cassette Bucky ﻳﻮﻧﻴﻮ ﻟﻮﻃﻨﻴﻦ ﺍﻟﺴﻴﺎﺳﻲ ﻟﻠﻤﺮﺍﺗﺐ ﺍﻟﻤﺘﻮﺳﻂ ﺍﻟﻤﺘﻮﺍﺿﻊ ﺍﻟﻤﺘﺎﺣﺔ ﺍﻟﻤﺘﺎﺣﺔ ﺍﻟﻌﺎﻡ ﺍﻟﻤﺘﺎﺣﺪ ﺍﻟﻤﺘﺎﺣﺪ ﺍﻟﻌﺎﺩﻟﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺎﺣﺪ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺎﺑﻌﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺎﺑﻌﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻘﺎﺩ ﺍﻟﻤﺘﺤﺪﺓ in sug doily .unu c.cl x mm 0.282 × um 0.282 × um 0.282 × mm winioni
- Xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx
- topad IPU-2 (Interface and Power Un
- KRpad LPT2 Detector Cable
- XRpad Protective Insert 307
- OV Cable IEC 60320 C13
- ........ Cable IEC 60320 CLS
- frigger Cable 5 m/16.5
- ger Cable 20 m/65
- GigE Interface Cable 15.25 m/ Interface Cable 7.6 m/2
- E Interface Cable 30.5 m/100
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
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)
PerkinElmer has performed internal non-clinical testing and BE and MTF are comparable to the predicate device.
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.
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
§ 892.1680 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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around the perimeter. In the center is a stylized graphic of what appears to be a human figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 1, 2016
PerkinElmer, Inc. % Ms. Dawn M. Spooner Associate Director, Regulatory Affairs 940 Winter Street WALTHAM MA 02451
Re: K161942
Trade/Device Name: XRpad2 3025 HWC-M Flat Panel Detector Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: July 14, 2016 Received: July 15, 2016
Dear Ms. Spooner:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael D'Hara
For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K161942
Device Name
XRpad2 3025 HWC-M Flat Panel Detector
Indications for Use (Describe)
The XRpad2 3025 HWC-M, when used with a radiographic imaging system, is indicated for use in generating radiographic images of human anatomy for diagnostic X-ray procedures, wherever conventional screen-film (SF), digital radiography (DR), or computed radiography (CR) systems may be used. It is not intended for mammonfions .
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
olsand
əsinə aid bərində aid bir və qarşına qalındığı var. Azərbaycan filmlərinin siyahıya əlin qırmızı viri
The assigned 510(k) number is: X161942
910Z 'SI Isnany
| Submitted By: | PerkinElmer Medical Imaging
2175 Mission College Blvd.
Santa Clara, CA 95054
U.S.A. |
|-------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Dawn Spooner
Associate Director, Regulatory Affairs
Tel. 781-663-6071
Fax. 781-663-5969 |
| Device Name: | PerkinElmer XRpad2 3025 HWC-M Flat Panel Detector |
| Classification: | Product Code: MQB
Classification Name: Stationary X-ray System
Classification Regulation: 21 CFR 892.1680 |
| Predicate Device: | PerkinElmer XRpad 4336 MED Flat Panel Detector
510(k) Clearance: K140551; August 1, 2014
Product Code: MQB
Classification Name: Stationary X-ray System
Classification Regulation: 21 CFR 892.1680 |
4
evice Description
standard X-ray cassette Bucky ﻳﻮﻧﻴﻮ ﻟﻮﻃﻨﻴﻦ ﺍﻟﺴﻴﺎﺳﻲ ﻟﻠﻤﺮﺍﺗﺐ ﺍﻟﻤﺘﻮﺳﻂ ﺍﻟﻤﺘﻮﺍﺿﻊ ﺍﻟﻤﺘﺎﺣﺔ ﺍﻟﻤﺘﺎﺣﺔ ﺍﻟﻌﺎﻡ ﺍﻟﻤﺘﺎﺣﺪ ﺍﻟﻤﺘﺎﺣﺪ ﺍﻟﻌﺎﺩﻟﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺎﺣﺪ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺎﺑﻌﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺎﺑﻌﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻘﺎﺩ ﺍﻟﻤﺘﺤﺪﺓ in sug doily .unu c.cl x mm 0.282 × um 0.282 × um 0.282 × mm winioni
- Xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx
- topad IPU-2 (Interface and Power Un
- KRpad LPT2 Detector Cable
- XRpad Protective Insert 307
- OV Cable IEC 60320 C13
- ........ Cable IEC 60320 CLS
- frigger Cable 5 m/16.5
- ger Cable 20 m/65
- GigE Interface Cable 15.25 m/ Interface Cable 7.6 m/2
- E Interface Cable 30.5 m/100
Indications For Use
əsn ondare o (ЯП) үүдбэлэгийн төрий (ЧЗ) шүү-пээлэг төлөлтөлтөг тэлэгээгүй хэлийн хэлийн хэлийн хэлийн and and
5
Comparison Chart
| Characteristics | ||
|---|---|---|
| Intended Use / | ||
| Indications for | ||
| Use | The XRpad 4336 MED when used | |
| with a radiographic imaging system, is | ||
| indicated for use in generating | ||
| radiographic images of human | ||
| anatomy for diagnostic X-ray | ||
| procedures, wherever conventional | ||
| screen-film (SF), digital radiography | ||
| (DR), or computed radiography (CR) | ||
| systems may be used. It is not intended | ||
| for mammographic use. | Same | |
| Model | PerkinElmer | |
| XRpad 4336 MED | ||
| (K140551) | Proposed Model | |
| PerkinElmer | ||
| XRpad2 3025 HWC-M | ||
| Panel | ||
| Scintillator | Direct deposition CsI:Tl | Same |
| Pixel pitch | $100 \mu m$ | Same |
| Pixel matrix | 3556 × 4320 pixels | 2508 × 3004 |
| Limiting | ||
| resolution | 5 lp/mm | Same |
| Binning | ||
| capable | 2 x 2 binning for 200 $\mu m$ | Same |
| Data transmit | ||
| area | 355 mm x 432 mm | 250 mm x 300 mm |
| External | ||
| dimensions | ||
| (w x l x h) | 384 mm x 460 mm × 15 mm | 282 mm x 332 mm × 15.5 mm |
| Weight | 3.8 kg | 1.8 kg |
| Housing | ||
| material | Aluminum with carbon-fiber | Same |
| Finish | Matte carbon-fiber front with white | |
| silk-screen active area markers | Same | |
| Communication | ||
| interface | Gb Ethernet or 802.11n WiFi | Same |
| WiFi band | 5.1-5.3 GHz | 5.1-5.9 GHz |
| X-ray | ||
| synchronization | ||
| interface | Dedicated trigger in/out signal lines or | |
| Automatic Exposure Detection | Same | |
| Power | External power supply or battery | Same |
| Software | ||
| library | Windows OS | Windows and Linux OS |
6
Summary of Studies
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Summary of Non-Clinical Data
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7
Substantist Equiivalency
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Conclusion.
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