(23 days)
No
The summary does not mention AI, ML, deep learning, or any related terms, nor does it describe features or performance metrics typically associated with AI/ML-powered devices (e.g., training/test sets, AUC, sensitivity/specificity for algorithmic performance). The description focuses on standard digital radiography technology and image processing.
No
The device is described as a diagnostic X-ray angiography system used to obtain and process images for diagnostic and interventional cardiac examinations, not to provide therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states, "This X-ray anglography system is indicated for use in diagnostic and interventional cardiac examinations."
No
The device description explicitly states it is "equipment" and includes a "Flat Panel Detector (FPD)," which is a hardware component. While it processes and displays images, it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases, conditions, or infections.
- Device Description: The description clearly states this is a "digital radiography system" that uses an "X-ray angiography system configuration" and a "Flat Panel Detector (FPD)". It processes and displays digital images obtained from X-rays.
- Intended Use: The intended use is for "diagnostic and interventional cardiac examinations" using X-ray angiography. This involves imaging the inside of the body using X-rays and contrast agents, not analyzing samples taken from the body.
The device is an imaging system used for diagnostic and interventional procedures, which falls under the category of medical devices, but not specifically In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
This device is a digital radiography used in diagnostic X-ray angiography system configuration.
This X-ray angiography system is indicated for use in diagnostic and interventional cardiac examinations.
It is intended to replace images obtained through the image intensifier technology.
Product codes (comma separated list FDA assigned to the subject device)
IZI, MOB
Device Description
This equipment is a digital radiography with Flat Panel Detector (FPD) used in diagnostic X-ray angiography system configuration. This equipment processes, displays, and records digital images obtained from the Flat Panel Detector, and it replays the recorded images.
Mentions image processing
This equipment processes, displays, and records digital images obtained from the Flat Panel Detector, and it replays the recorded images.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-Ray
Anatomical Site
cardiac
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): 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.
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
§ 892.1600 Angiographic x-ray system.
(a)
Identification. An angiographic x-ray system is a device intended for radiologic visualization of the heart, blood vessels, or lymphatic system during or after injection of a contrast medium. 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
KO41027
R 1 72
MAY 1 4 2004
510(k) SUMMARY
| 1. DEVICE NAME: | Solid State X-Ray Imager |
|---|---|
| Model Name: | DFP-8000D / FPD |
| Trade/Proprietary Name: | Digital Radiography System with Flat Panel Detector (FPD) |
-
- ESTABLISHMENT REGISTRATION: 2020563
- U.S. Agent Name and Address: 3. TOSHIBA AMERICA MEDICAL SYSTEMS,INC. 2441 MICHELLE DRIVE TUSTIN, CA 92780
Contact Person:
Senior Regulatory Affairs Specialist (714) 730 - 5000 Manufacturing Site:
Michaela Mahl
TOSHIBA MEDICAL SYSTEMS CORPORATION 1385 Shimoishigami Otawara-shi, Tochigi 324-8550, Japan
-
- Date of Submission: April 08, 2004
7. DEVICE DESCRIPTION This equipment is a digital radiography with Flat Panel Detector (FPD) used in diagnostic X-ray angiography system configuration. This equipment processes, displays, and records digital images obtained from the Flat Panel Detector, and it replays the recorded images.
8. SUMMARY of INTENDED USE
This device is a digital radiography used in diagnostic X-ray angiography system configuration.
This X-ray angiography system is indicated for use in diagnostic and interventional cardiac examinations.
It is intended to replace images obtained through the image intensifier technology.
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p. 242
9. EQUIVAALENCY INFORMATION
TOSHIBA Medical Systems Corporation believes that the new Digital Radiography System, model DFP-8000D/FDP is substantially equivalent to the current Digital Radiography System, model DFP-8000D (K013608) with Image Intensifier (model RTP9211J-G11) (K993038) except for the new Flat Panel Detector (FPD).
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring a symbol that resembles a caduceus or a staff with snakes, representing health and medicine.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Toshiba America Medical Systems. Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street NW BUFFALO MN 55313
AUG 23 2013
Re: K041027
Trade/Device Name: Digital Radiography Systems with Flat Panel Detector, Model DFP-8000D/FDP Regulation Number: 21 CFR 892.1600 Regulation Name: Angiographic x-ray system Regulatory Class: II Product Code: IZI and MOB Dated: April 15, 2004 Received: April 21, 2004
Dear Mr. Job:
This letter corrects our substantially equivalent letter of May 14, 2004.
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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting of
3
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours,
Janine M. Morris
Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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TAB B 1
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of
Page
K041027 510(k) Number (if known):
Device Name: Digital Radiography System with Flat Panel Detector, Model DFP-8000D/FDP
Indications for Use:
This device is a digital radiography system used in diagnostic X-ray angiography system configuration.
This X-ray anglography system is indicated for use in diagnostic and interventional cardiac examinations.
It is intended to replace images obtained through the image intensifier technology.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
...
David R. Lagmm
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number RO41027