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Found 4 results
510(k) Data Aggregation
K Number
K193189Device Name
RFID Localization System
Manufacturer
Health Beacons, Inc.
Date Cleared
2020-05-06
(169 days)
Product Code
NEU
Regulation Number
878.4300Why did this record match?
Applicant Name (Manufacturer) :
Health Beacons, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Tag of the RFLS is intended for percutaneous placement in the breast to mark (>30 days) a lesion intended for surgical removal. Using image guidance (such as ultrasound or radiography) or aided by non-imaging guidance (RFLS), the RFID Tag is located and surgically removed with the target tissue. The RFLS is intended only for the non-imaging detection and localization of the Tag that has been implanted in a lesion intended for surgical removal.
Device Description
The proposed RFID Localization System is a marker-with-detector localization device that employs miniature RFID tags as markers and a hand-held reader that can measure distance to the tag. The RFLS is comprised of a Tag, Tag Applicator/Tag Applicator S, LOCalizer Reader) and LOCalizer Surgical Probe (Surgical Probe). The Tag, when used in conjunction with the Reader and Surgical Probe, can be used as a guide for the surgeon to refer to in the excision of tissue. The RFLS is a prescription device meant only for use by trained professionals.
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K Number
K190932Device Name
RFID Localization System
Manufacturer
Health Beacons, Inc.
Date Cleared
2019-09-13
(156 days)
Product Code
NEU
Regulation Number
878.4300Why did this record match?
Applicant Name (Manufacturer) :
Health Beacons, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Tag of the RFLS is intended for percutaneous placement in the breast to mark (>30 days) a lesion intended for surgical removal. Using image guidance (such as ultrasound or radiography) or aided by non-imaging guidance (RFLS), the RFID Tag is located and surgically removed with the target tissue. The RFLS is intended only for the non-imaging detection and localization of the Tag that has been implanted in a lesion intended for surgical removal.
Device Description
The Tag, Tag Applicator, Tag Applicator S, LOCalizer Reader, and LOCalizer Surgical Probe are components of the Health Beacons RFID Localization System (RFLS). The proposed device is a marker-with-detector localization device that employs miniature RFID tags as markers and a handheld reader that can measure distance to the Tag. The Tag, when used in conjunction with the Reader and Surgical Probe, can be used as a guide for the surgeon during the excision of tissue. The RFLS is a prescription device meant only for use by trained professionals, specifically breast surgeons and diagnostic radiologists.
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K Number
K181692Device Name
5cm Tag Applicator, 7cm Tag Applicator, 10 cm Tag Applicator, 5 cm Tag Applicator (10 pack), 7cm Tag Applicator (10 pack), 10cm Tag Applicator (10 pack), LOCalizer Surgical Probe, LOCalizer Surgical Probe (5 pack)
Manufacturer
Health Beacons, Inc.
Date Cleared
2018-09-25
(90 days)
Product Code
NEU
Regulation Number
878.4300Why did this record match?
Applicant Name (Manufacturer) :
Health Beacons, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Tag of the RFLS is intended for percutaneous placement in the breast to mark (>30 days) a lesion intended for surgical removal. Using image guidance (such as ultrasound or radiography) or aided by non-imaging guidance (RFLS), the RFID Tag is located and surgically removed with the target tissue. The RFLS is intended only for the non-imaging detection and localization of the Tag that has been implanted in a lesion intended for surgical removal.
Device Description
The Tag, Tag Applicator, LOCalizer Reader, and LOCalizer Surgical Probe are components of the Health Beacons RFID Localization System (RFLS). The proposed device is a marker-with-detector localization device that employs miniature RFID tags as markers and a hand-held reader that can measure distance to the Tag, when used in conjunction with the Reader and Surgical Probe, can be used as a guide for the surgeon during the excision of tissue. The RFLS is a prescription device meant only for use by trained professionals, specifically breast surgeons and diagnostic radiologists.
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K Number
K163667Device Name
RFID Localization System- Localizer Reader, RFID Localization System- Localizer Surgical Probe, RFID Localization System- Localizer Surgical Probe (5 pack), RFID Localization System- Tag Applicator, RFID Localization System -Tag Applicator (10 pack)
Manufacturer
HEALTH BEACONS, INC.
Date Cleared
2017-04-28
(122 days)
Product Code
PBY
Regulation Number
878.4300Why did this record match?
Applicant Name (Manufacturer) :
HEALTH BEACONS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Tag of the RFLS is intended for percutaneous placement in the breast to temporarily (<30 days) mark a lesion intended for surgical removal. Using image guidance (such as ultrasound or radiography) or aided by non-imaging guidance (RFLS), the RFID Tag is located and surgically removed with the target tissue.
The RFLS is intended only for the non-imaging detection and localization of the Tag that has been implanted in a lesion intended for surgical removal.
Device Description
The RFID Localization System (RFLS) is a marker-with-detector localization device that employs miniature RFID tags as markers and a hand-held reader that can measure distance to the tag. The RFLS is comprised of a Tag, Tag Applicator, Reader, and Surgical Probe. The Tag, when used in conjunction with the Reader and Surgical Probe, can be used as a guide for the surgeon during the excision of tissue. The RFLS is a prescription device meant only for use by trained professionals, specifically breast surgeons and diagnostic radiologists.
Ask a Question
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