(47 days)
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No
The document describes standard image reconstruction techniques and does not mention AI, ML, or related concepts.
No.
The device is described as an imaging system (CT and angiography) used to produce cross-sectional images for diagnostic purposes and to support interventional radiological techniques, rather than directly treating a disease or condition.
Yes
The device, Angio-CT MIYABI, is described as intended to "produce cross-sectional images of the body" and "allows interventional radiological techniques, and whole body x-ray computed tomography scanning." The production of images for the purpose of visualization and assessment of the body falls under the definition of diagnostic use.
No
The device description clearly states it is a combination of a CT and an Angiography system, which are hardware-based imaging modalities. While software is involved in image reconstruction, the core device is hardware.
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 taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device function: The description clearly states that the Angio-CT MIYABI system is a combination of a CT and an Angiography system. These systems use X-rays to produce images of the inside of the body.
- Intended Use: The intended use is to produce cross-sectional images of the body and facilitate interventional radiological techniques. This involves imaging the patient directly, not analyzing samples taken from the patient.
Therefore, the Angio-CT MIYABI system falls under the category of medical imaging devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The SOMATOM Plus 4 is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angels or spiral planes* taken at different angles. (*Spiral planes: the axial planes resulted from the continuous rotation of detectors and x-ray tube and the simultaneous movement of the sliding gantry). The Multistar Plus is a ceiling-suspended double C-arm for single plane general vascular imaging as well as interventional techniques.
Angio-CT MIYABI is a combined system, which allows interventional radiological techniques, and whole body x-ray computed tomography scanning on a single patient without moving the patient from one table to another especially after or during interventional procedure performed under image intensified visualization (e.g. stenting, coiling, local chemical therapy, embolization).
Product codes (comma separated list FDA assigned to the subject device)
90 IXI, 90 JAK
Device Description
The Angio-CT MIYABI system is a combination of a CT and an Angiography system The SOMATOM Plus 4 system is a whole body X-ray computed tomography scanner which features a continuously rotating tube-detector system and functions according to the fan beam principle. The Multistar Plus is a ceiling-suspended double C-arm for single plane general vascular imaging as well as interventional techniques.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
X-ray computed tomography, Angiography
Anatomical Site
Body (whole body)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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
§ 892.5710 Radiation therapy beam-shaping block.
(a)
Identification. A radiation therapy beam-shaping block is a device made of a highly attenuating material (such as lead) intended for medical purposes to modify the shape of a beam from a radiation therapy source.(b)
Classification. Class II.
0
Attachment 1
Summary of Safety and Effectiveness
This summary of 510(k)-safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
I. General Information
| Device Name: | Angio-CT MIYABI |
|---|---|
| Classification Name: | § 892.1750: |
| Computed tomography X-ray system | |
| § 892.1600 | |
| Angiographic x-ray system | |
| Propriety Trade Name: | Angio-CT MIYABI |
| Classification: | Class II |
| Performance Standards: | 21 CFR Subchapter J, Federal |
| Diagnostic X-ray Equipment Standard | |
| Establishment Regist. Number: | 2240869 |
| Address: | Siemens Medical Systems, Inc. |
| 186 Wood Avenue South | |
| Iselin, NJ 08830 | |
| Contact Person: | Kathleen M. Rutherford |
| Manager, Regulatory Submissions | |
| (732) 321-4779 |
1
SIEMENS
II. Safety and Effectiveness Information Supporting the Substantial Equivalence Determination
Device Description:
The Angio-CT MIYABI system is a combination of a CT and an Angiography system The SOMATOM Plus 4 system is a whole body X-ray computed tomography scanner which features a continuously rotating tube-detector system and functions according to the fan beam principle. The Multistar Plus is a ceiling-suspended double C-arm for single plane general vascular imaging as well as interventional techniques.
Intended Use:
The SOMATOM Plus 4 is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angels or spiral planes* taken at different angles. (*Spiral planes: the axial planes resulted from the continuous rotation of detectors and x-ray tube and the simultaneous movement of the sliding gantry). The Multistar Plus is a ceiling-suspended double C-arm for single plane general vascular imaging as well as interventional techniques.
Angio-CT MIYABI is a combined system, which allows interventional radiological techniques, and whole body x-ray computed tomography scanning on a single patient without moving the patient from one table to another especially after or during interventional surgery (e.g. stenting, coiling, local chemical therapy, embolization).
Technological Characteristics:
The Angio-CT MIYABI system is a combination of a CT and an Angiography system.
General Safety and Effectiveness Concerns:
All components of the Angio-CT MIYABI system subject to the Federal Diagnostic Equipment Performance Standard and applicable regulations of 21CFR § 1020.30 and § 1020.33 are certified to meet those requirements; and an initial report as per 21 CFR § 1002.10 will be filed with the Center for Devices and Radiological Health (CDRH). To minimize electrical, mechanical, and radiation hazards, Siemens adheres to recognized and established industry practice. The SOMATOM is designed to meet the ELECTRICAL AND MECHANICAL SAFETY STANDARD IEC 601-1 and UL 187 X-RAY EQUIPMENT STANDARD FOR SAFETY.
Substantial Equivalence:
The Angio-CT MIYABI operating with SOMARIS 4 (SOMATOM Plus 4) and SW-Version 3,0 (Multistar Plus) software is substantially equivalent to the SOMATOM Plus 4 and Multistar Plus systems with Koordinat M in commercial distribution.
Kathleen Rutherford
Signature
2/16/99
Date
2
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 5 1999
Alicia Bustos-Juergensen Technical Specialist Siemens Medical Systems, Inc. 186 Wood Avenue South Iselin, NJ 08830
Re:
K990491 Angio-CT MIYABI Dated: February 16, 1999 Received: February 17, 1999 Regulatory classs: II 21 CFR 892.1600/Procode: 90 IXI 21 CFR 892.1750/Procode: 90 JAK
Dear Ms. Bustos-Juergensen:
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 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). 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 (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 (QS) 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(t) 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 vitro diagnostic 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 requlation 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/cdrh/dsma/dsmamain.html".
Sincerely yours,
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Attachment 2
Indication for use
996491
510(k) Number (if known):
Device Name:
Angio-CT MIYABI
Indication for use:
The SOMATOM Plus 4 is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angels or spiral planes* taken at different angles. (*spiral planes: the axial planes resulted from the continuous rotation of detectors and x-ray tube, and the simultaneous movement of the sliding gantry.)
The Multistar Plus is a ceiling-suspended double C-arm for single plane general vascular imaging as well as interventional techniques.
Angio-CT MIYABI is a combined system, which allows interventional radiological techniques, and whole body x-ray computed tomography scanning on a single patient without moving the patient from one table to another especially after or during interventional procedure performed under image intensified visualization (e.g. stenting, coiling, local chemical therapy, embolization).
David A. Seigman
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological D 510(k) Number
Prescription Use
(Per 21 CFR 801.109)