(22 days)
No
The summary describes a standard CT scanner with software for image reconstruction and management, with no mention of AI or ML features.
No.
The device is used for imaging (diagnosis) rather than providing therapy.
Yes
The device is described as producing "cross-sectional images of the body by computer reconstruction of x-ray transmission data," which is a fundamental aspect of diagnostic imaging for medical evaluation.
No
The device description explicitly states it is a "16 slice, whole body X-ray computed tomography system," which is a hardware device. While it includes software, it is not solely software.
Based on the provided information, the Siemens SOMATOM Emotion 16 is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to produce cross-sectional images of the body using X-ray transmission data. This is a form of in vivo imaging, meaning it is used to examine the inside of a living body.
- Device Description: The description confirms it's an X-ray computed tomography system, which is an imaging modality used on patients.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue) or performing tests on these samples outside of the body, which are the defining characteristics of an IVD.
Therefore, the SOMATOM Emotion 16 is a medical imaging device used for diagnostic purposes, but it operates in vivo rather than in vitro.
N/A
Intended Use / Indications for Use
The SOMATOM Emotion 16 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 translation of the patient. )
Product codes
90 JAK
Device Description
The Siemens SOMATOM Emotion 16 system is a 16 slice, whole body X-ray computed tomography systems, which features a continuously rotating tube-detector system and functions according to the fan beam principle. The software is syngo-based Somaris/5 software version VB28, which is a command-based program used for patient management, data management, X-ray scan control, image reconstruction, and image archive/evaluation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray transmission data
Anatomical Site
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
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. 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
510(K) SUMMARY FOR SOMATOM PROJECT P10G
Submitted by: Siemens Medical Solutions, Inc. USA 51 Valley Stream Parkway Malvern, PA 19355
February 4, 2005
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.
1. Contact Person:
14
Ms. Debra Peacock Technical Specialist, Regulatory Affairs Submissions Siemens Medical Solutions, Inc. USA
51 Valley Stream Parkway E-50 Malvern, PA 19355 Phone: +1 (610) 448-1773 Fax: +1 (610) 448-1787
Koso29
2. Device Name and Classification
| Product Name: | SOMATOM Emotion 16 |
|---|---|
| Classification Name: | Computed Tomography System |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR §892.1750 |
| Device Class: | Class II |
| Product Code: | 90 JAK |
3. Substantial Equivalence:
Siemens SOMATOM P10G Computed Tomography X-ray systems, configured with software version SOMARIS/5 is substantially equivalent to the following medical device in commercial distribution:
| Predicate Device Name | FDA Clearance Number | FDA Clearance Date |
|---|---|---|
| Siemens SOMATOM Emotion 6 | K023687 | 11/22/2002 |
1
Device Description: 4.
The Siemens SOMATOM Emotion 16 system is a 16 slice, whole body X-ray computed tomography systems, which features a continuously rotating tube-detector system and functions according to the fan beam principle. The software is syngo-based Somaris/5 software version VB28, which is a command-based program used for patient management, data management, X-ray scan control, image reconstruction, and image archive/evaluation.
Indications for Use: ડ.
The SOMATOM Emotion 16 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 translation of the patient. )
General Safety and Effectiveness Concerns: 6.
The device labeling contains instructions for use and any necessary cautions and warnings, to provide for safe and effective use of the device.
Risk management is ensured via a hazard analysis, which is used to identify potential hazards. These potential hazards are controlled via software development, verification and validation testing. To minimize electrical, mechanical, and radiation hazards, Siemens adheres to recognized and established industry practice and standards.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three curved lines representing its wings or feathers. The overall design is simple and conveys a sense of official government branding.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 - 2005
Ms. Debra Peacock Technical Specialist, Regulatory Affairs Submissions Siemens Medical Solutions, Inc. USA 51 Valley Stream Parkway MALVERN PA 19355
Re: K050297 Trade/Device Name: SOMATOM Project P10G (SOMATOM Emotion 16) Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: 90 JAK Dated: February 4, 2005 Received: February 9, 2005
Dear Ms. Peacock:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we have revewed your section 510(t) prehestantially equivalent (for the indications for use stated in above and nave decemined the ac needicate devices marketed in interstate commerce prior to the enclosure) to regary maneled problements, or to device Amendments, or to devices that have been May 26, 1970, the chaculient date of the Federal Food, Drug, and Cosmetic Act (Act) that fectassified in accordatics with the pro horena al application (PMA). You may, therefore, market the do not require approval on a promation approvisions of the Act. The general controls provisions of the Act device, subject to the general controls provided to the severes, 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 If your device is classified (see as re) additional controls. Existing major regulations affecting your Apploval), it thay be subject to cash aderal Regulations, Title 21, Parts 800 to 898. In addition, FDA device can be round in the courseming your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that I reast of advised mar 1127 is issual 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 receial statues and regulation. administer to registration and listing (21 CFR Part 807); labeling Act STEQuirements, moducing, but no a practice requirements as set forth in the quality systems (QS) (21 CFR Part 801); and if applicable, the clectronic 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) This letter will allow you to begin hanceling of substantial equivalence of your device to a legally
premarket notification. The FDA finding of substantial equivale vour dev premarket notification. The PDA midnig of saosantal organical organits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your device on our labeling regulation (
contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR A lso, please note the regulation chilited, "frisonalians of your responsibilities under the Act from the (8) 807.97). You may obtain other general information on your bely and its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.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
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SECTION 3 INDICATION FOR USE
510(k) Number (if known):
Ko 50297
Device Name:
SOMATOM Project P10G (SOMATOM Emotion 16)
The Siemens SOMATOM Emotion 16 system 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 angles 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 translation of the patient.)
(Please do not write below this line - continue on another page if needed)
【ASSESSENTACCACTETACCTSTCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCC
Concurrence of the CDRH, Office of Device Evaluation (ODE)
Prescription Use i
(Per 21 CFR §801.109)
OR Over-The-Counter Use
David W. Ingram
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices KOSO24 510(k) Number _
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