(85 days)
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No
The provided text describes a standard angiographic imaging system and does not mention any AI or ML capabilities, image processing features that might imply AI/ML, or details about training/test sets which are common in AI/ML device submissions.
No
The device is intended for diagnostic angiographic fluoroscopy and radiography/cardiography studies, which are diagnostic purposes, not therapeutic.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended for general purpose diagnostic angiographic fluoroscopy and radiography study" and "general purpose diagnostic angiographic fluoroscopy and cardiography study," directly labeling its purpose as diagnostic.
No
The device description explicitly states it is an "angiographic and radiographic biplane positioner" and includes physical components like a "vascular table and an x-ray system," indicating it is a hardware-based medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The provided text describes an angiographic imaging system that uses x-rays to visualize blood vessels and other structures within the body. This is an in vivo (within the living body) imaging technique, not an in vitro (outside the living body) diagnostic test.
- Intended Use: The intended use clearly states "general purpose diagnostic angiographic fluoroscopy and radiography study" and "general purpose diagnostic angiographic fluoroscopy and cardiography study." These are procedures performed directly on the patient, not on samples taken from the patient.
Therefore, based on the provided information, the Advantx LCN+ and LCLP+ angiographic imaging systems are not IVDs. They are medical imaging devices used for diagnostic purposes through the application of x-rays to the patient.
N/A
Intended Use / Indications for Use
The Advantx LCN+ angiographic imaging system is intended for general purpose diagnostic angiographic fluoroscopy and radiography study.
The Advantx LCLP+ angiographic imaging system is intended for general purpose diagnostic angiographic fluoroscopy and cardiography study.
The Advantx LCN+ is a biplane x-ray system consisting of a floor mounted three-axis C-arm and a ceiling suspended C-arm that addresses all angiographic procedures that require a 32 cm Image Intensifier.
The Advantx LCLP+ is a biplane x-ray system consisting of a floor mounted three-axis C-arm and a ceiling suspended C-arm that addresses all angiographic procedures that require a 22 cm Image Intensifier.
Product codes (comma separated list FDA assigned to the subject device)
90 IZI
Device Description
The Advantx LCN+ angiographic imaging system is an angiographic and radiographic biplane positioner for use with the x-ray system Advantx. It consists of an angiographic biplane positioner, a vascular table and an x-ray system.
- Materials: All construction and materials are compliant with UL 187.
- Design: There are hardware and software redundancies to prevent single point failures that could cause unintended motion.
- Energy Source: 220 V AC 50/60 Hz
The Advantx LCLP+ angiographic imaging system is an angiographic and cardiographic biplane positioner for use with the x-ray system Advantx. It consists of an angiographic biplane positioner, a vascular table and an x-ray system. All construction and materials are compliant with UL 187.
- Design: There are hardware and software redundancies to prevent single point failures that could cause unintended motion.
- Energy Source: 220 V AC 50/60 Hz
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
x-ray
Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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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)
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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.
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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).
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§ 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
FEB 1 3 1998
Image /page/0/Picture/2 description: The image shows the text "GE Medical Systems" in bold, black font. The text is stacked on one line. The font appears to be sans-serif.
P.O. Box 414, W-709 Milwaukee, WI 53201 USA
510(K) SUMMARY OF SAFETY and EFFECTIVENESS
This 510(k) summary of safety and effectiveness is submitted in accordance with the requirements of 21CFR part 807.87(h).
Identification of Submitter
Larry A. Kroger, Ph.D. Senior Manager of Regulatory Programs Telephone: (414)544-3894 Date Prepared: October 31, 1997
Identification of the Product
| Name: | Advantx LCN+ angiographic imaging system |
|---|---|
| Manufacturer: | GE Medical Systems - Europe |
| 283, rue de la Miniere | |
| 78533 Buc Cedex, FRANCE | |
| Distributed by: | GE Medical Systems, Milwaukee, WI |
Marketing History
The Advantx LCN+ x-ray angiographic system is substantially equivalent to currently marketed angiographic imaging systems that comply with the same or equivalent standards and have the same intended uses.
Device Descriptions
The Advantx LCN+ angiographic imaging system is an angiographic and radiographic biplane positioner for use with the x-ray system Advantx. It consists of an angiographic biplane positioner, a vascular table and an x-ray system.
| Materials: | All construction and materials are compliant with UL 187. |
|---|---|
| Design: | There are hardware and software redundancies to prevent single |
| point failures that could cause unintended motion. | |
| Energy Source: | 220 V AC 50/60 Hz |
Indications for Use
The Advantx LCN+ angiographic imaging system is intended for general purpose diagnostic angiographic fluoroscopy and radiography study.
1
GE Medical Systems
P.O. Box 414, W-709 Milwaukee, WI 53201 USA
510(K) SUMMARY OF SAFETY and EFFECTIVENESS
Adverse Effects on Health
The potential hazards (unintended emission of x-rays, excessive radiation, mechanical and electrical hazards) are identified in a Risk Management Summary and controlled by:
- Failure Mode and Effects Analysis (FMEA) to demonstrate the non-existence . or extremely low probability of unwanted events.
- System evaluation to insure performance to specification and Federal . Regulations.
- Adherence to Industrial Standards (UL) .
Conclusions
100
The Advantx LCN+ angiographic imaging system complies with 21CFR and UL 187. This system poses no added safety risk.
2
GE Medical Systems
P.O. Box 414, W-709 Milwaukee, WI 53201 USA
510(K) SUMMARY OF SAFETY and EFFECTIVENESS
This 510(k) summary of safety and effectiveness is submitted in accordance with the requirements of 21CFR part 807.87(h).
Identification of Submitter
Larry A. Kroger, Ph.D. Senior Manager of Regulatory Programs Telephone: (414)544-3894 Date Prepared: October 31, 1997
Identification of the Product
Advantx LCLP+ angiographic imaging system Name:
GE Medical Systems - Europe Mfg.: 283, rue de la Miniere 78533 Buc Cedex, FRANCE
Marketing History
The Advantx LCLP+ x-ray angiographic system is substantially equivalent to currently marketed angiographic x-ray systems that comply with the same or equivalent standards and have the same intended uses.
Device Descriptions
The Advantx LCLP+ angiographic imaging system is an angiographic and cardiographic biplane positioner for use with the x-ray system Advantx. It consists of an angiographic biplane positioner, a vascular table and an x-ray system. All construction and materials are compliant with UL 187. Materials: There are hardware and software redundancies to prevent single Design: point failures that could cause unintended motion.
Energy Source: 220 V AC 50/60 Hz
Indications for Use
The Advantx LCLP+ angiographic imaging system is intended for general purpose diagnostic angiographic fluoroscopy and cardiography study.
Image /page/2/Picture/16 description: The image shows the fraction 3/4. The number 3 is above a horizontal line, and the number 4 is below the horizontal line. This is a common way to represent fractions in mathematics.
3
●
P.O. Box 414. W-709 Milwaukee, WI 53201 USA
510(K) SUMMARY OF SAFETY and EFFECTIVENESS
Adverse Effects on Health
The potential hazards (unintended emission of x-rays, excessive radiation, mechanical and electrical hazards) are identified in a Risk Management Summary and controlled by:
- Failure Mode and Effects Analysis (FMEA) to demonstrate the non-existence . or extremely low probability of unwanted events.
- System evaluation to insure performance to specification and Federal . Regulations.
- Adherence to Industrial Standards (UL) .
Conclusions
The Advantx LCLP+ angiographic imaging system complies with 21CFR and UL 187. This system poses no added safety risk.
4
Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird with three curved lines representing its wings or feathers. The bird is positioned above a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 3 1998
Larry A. Kroger, Ph.D. Regulatory Affairs Program Manager GE Medical Systems, Inc. P.O. Box 414 Milwaukee, WI 53201
Dear Dr. Kroger:
:
Re:
K974367 Advantx LCN+ & Advantx LCLP+ Dated: November 18, 1997 Received: November 20, 1997 Regulatory class: II 21 CFR 892.1600/Procode: 90 IZI
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 ise stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device 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 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 requirement, 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 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 predication 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 question 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/cdcbdsmamain.html"...............................................................................................
Sincerely yours.
h.7. liau Yu.
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
5
510(k) Number (if known):
Device Name: Advantx LCN+ and Advantx LCLP+ angiographic x-ray systems
Indications for Use
The Advantx LCN+ is a biplane x-ray system consisting of a floor mounted three-axis C-arm and a ceiling suspended C-arm that addresses all angiographic procedures that require a 32 cm Image Intensifier.
The Advantx LCLP+ is a biplane x-ray system consisting of a floor mounted three-axis C-arm and a ceiling suspended C-arm that addresses all angiographic procedures that require a 22 cm Image Intensifier.
(PLESE 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_
David C. Segerson
Division Sign Off
ivision Sign-Off) Division of Reproductive,
510(k) Number K974367