FDA.reportPublic FDA data

Halo Medical Technologies

Primary DI
00860008657343
Brand
Halo Medical Technologies
Company
Halo Medical Technologies, LLC
Model
HMT-MCP
Device description
MidCrystal Probe 2D
Published
2023-09-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
IYOSystem, imaging, pulsed echo, ultrasonic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYOSystem, Imaging, Pulsed Echo, UltrasonicRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K140899000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140899000HALO MEDICAL TECHNOLOGIES CATALYST MIDCRYSTL HALO ULTRASOUND SYSTEMHalo Medical Technologies, LLC2014-05-05IYO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860008657343PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860008657343008600086573438600086573430860008657343

GMDN Terms#

Term, Definition table
TermDefinition
Rectal/vaginal ultrasound imaging transducerAn invasive component of an ultrasound imaging assembly designed to be positioned within the vagina and/or rectum, either manually or under endoscopic guidance, for ultrasound imaging from within the vagina/rectum. Sometimes referred to as an ultrasound probe, it converts electric voltages into ultrasound which it transmits, detects resulting echoes, and transmits a proportional signal/data to another device for display; it does not include an integrated display. It may be intended for wired or wireless data transfer and may be intended for use with a dedicated ultrasound system or with an off-the-shelf device (e.g., smartphone) with dedicated software installed. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
065084024
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860008657305Halo Medical TechnologiesHMT-AIOSYS2023-09-29
00860008657312Halo Medical TechnologiesHMT-LTSYS2023-09-29
00860008657329Halo Medical TechnologiesHMT-TRP2023-09-29
00860008657336Halo Medical TechnologiesHMT-TRP 3D2023-09-29
00860008657350Halo Medical TechnologiesHMT-MCP 3D2023-09-29
00860008657367Halo Medical TechnologiesHMT-EVG2023-09-29
00860008657374Halo Medical TechnologiesHMT-EVG 3D2023-09-29
00860008657381Halo Medical TechnologiesHMT-SURM2023-09-29
00860008657886Halo Med. TechnologiesHMT MCP2023-09-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00845225012939IntraSight PlusPhilips Image Guided Therapy CorporationIYO2026-05-26
00845225012946IntraSight PlusPhilips Image Guided Therapy CorporationIYO2026-05-26
06974405095104CarbonMedCarbon (Shenzhen) Medical Device Co., Ltd.IYO2026-05-26
06974405095159CarbonMedCarbon (Shenzhen) Medical Device Co., Ltd.IYO2026-05-26
06974405095166CarbonMedCarbon (Shenzhen) Medical Device Co., Ltd.IYO2026-05-26
D510DUS6000ADVANCED DIGITAL PORTABLE ULTRASONIC SYSTEM ADVANCED INSTRUMENTATIONS, INC.IYO2026-03-24
10841716103992ACIST HDi™ CartACIST MEDICAL SYSTEMS, INC.IYO2026-03-04
04987670102813DIAGNOSTIC ULTRASOUND SYSTEMCANON INC.IYO2026-03-01
06975345060108Color Doppler Diagnostic Ultrasound SystemJiangsu Tingsn Technology Co., Ltd.IYO2026-01-31
16978669290012Astrasono A5Pro Bladder ScannerAstrasono technology co.,ltd.IYO2026-01-15
20841436126346Tracking Bracket Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2025-12-31
00198953042816LOGIQGe Medical Systems, Ultrasound & Primary Care Diagnostics LlcIYO2025-12-05
00841517112141Sonosite MTFUJIFILM SONOSITE, INC.IYO2025-11-24
00841517112196Sonosite MTFUJIFILM SONOSITE, INC.IYO2025-11-24
16978669290005Astrasono A3Pro Bladder ScannerAstrasono technology co.,ltd.IYO2025-11-20
00198953001431Venue GoGe Medical Systems, Ultrasound & Primary Care Diagnostics LlcIYO2025-11-17
00198953079256VscanGE Vingmed Ultrasound ASIYO2025-11-17
00845225012984Patient Interface Module (PIMr)Philips Image Guided Therapy CorporationIYO2025-08-22
06971679948945Shear Wave Quantificational Ultrasound Diagnostic SystemWuxi Hisky Medical Technologies Co.,Ltd.IYO2025-08-05
00198953001073VenueGe Medical Systems, Ultrasound & Primary Care Diagnostics LlcIYO2025-07-31
00198953001097Venue GoGe Medical Systems, Ultrasound & Primary Care Diagnostics LlcIYO2025-07-31
06938396400484SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.IYO2025-07-21
06938396400965SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.IYO2025-07-21
06938396400972SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.IYO2025-07-21
06938396400989SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.IYO2025-07-21
06938396400996SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.IYO2025-07-21
06938396401016SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.IYO2025-07-21
06938396401023SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.IYO2025-07-21
06938396401030SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.IYO2025-07-21
06938396401047SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.IYO2025-07-21