(251 days)
Not Found
Not Found
No
The provided 510(k) summary contains no mention of AI, ML, deep learning, or any related concepts in the device description, intended use, or performance study sections.
No
Explanation: The device is used for radiography and radiographic tomography examinations, which are diagnostic procedures, not therapeutic ones.
No
The device is described as being used for "radiography and radiographic tomography examinations," which are imaging procedures. While imaging can be part of a diagnostic process, the description does not state that the device itself performs diagnosis or analyzes the images to provide diagnostic information. It serves as an imaging tool.
Unknown
The provided 510(k) summary lacks a device description, making it impossible to determine if the device is software-only or includes hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "radiography and radiographic tomography examinations". These are imaging techniques that involve generating images of the inside of the body using radiation.
- Nature of IVDs: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections.
The description clearly points to a device used for medical imaging of the body, not for testing samples from the body.
N/A
Intended Use / Indications for Use
To be used for radiography and radiographic tomography examinations as prescribed by a licensed physician.
Product codes
90 IZF, 90 IYB, 90 IZZ
Device Description
Not Found
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1740 Tomographic x-ray system.
(a)
Identification. A tomographic x-ray system is an x-ray device intended to be used to produce radiologic images of a specific cross-sectional plane of the body by blurring or eliminating detail from other planes. 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
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of three curved lines.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 17 1998
Kenneth J. H. Tice Vice President Official Correspondent Pausch Corporation 808 Shrewsbury Avenue Tinton Falls, NJ 07724-3002 Re:
Combi Elevator-2 & Combi Elevator- 2 Microtom Dated: March 27, 1997 Received: May 14, 1997 Regulatory class: II 21 CFR 892.1740/Procode: 90 IZF 21 CFR 892.1770/Procode: 90 IYB 21 CFR 892.1980/Procode: 90 IZZ
Dear Mr. Tice:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in yitto disgnostic devices), please contact the Office of Compliance at (301) 594-4613. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdri/dsmaldsmamain.html",
ಿಗೆ ಸಿನ್ನೇ
网
Sincerely yours,
William Yh
Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
1
TEL: (732) 747-6110 FAX: (732) 747-6882
INDICATION FOR USE STATEMENT
510(k) Number K973864
Device Name: Combi Elevator-2 and Combi Elevator-2 Microtom
Indications For Use:
, i
To be used for radiography and radiographic tomography examinations as prescribed by a licensed physician.
(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)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K973864
510k Combi Elevator-2 Indications for use statement Page 1 of 1
PAUSCH