FDA.reportPublic FDA data

Halo Med. Technologies

Primary DI
00860008657886
Brand
Halo Med. Technologies
Company
Halo Medical Technologies, LLC
Model
HMT MCP
Device description
Catalyst Ultrasound System -Portable
Published
2023-09-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
00860008657886PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860008657886008600086578868600086578860860008657886

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose ultrasound imaging systemA stationary or mobile (e.g., on wheels) assembly of devices designed to collect, display, and analyse ultrasound images during a variety of extracorporeal and/or intracorporeal (endosonography or endoscopic) ultrasound imaging procedures (e.g., cardiac, OB/GYN, endoscopy, breast, prostate, vascular, and intra-surgical imaging). It consists of a mains (AC-powered) data processing unit with integrated software and a monitor. It is typically presented as a mobile assembly which may support a wide variety of transducers and related application software packages; an ultrasound transducer(s) may be included.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
065084024
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860008657305Halo Medical TechnologiesHMT-MNISYS2023-09-29
00860008657312Halo Medical TechnologiesHMT-AIOSYS2023-09-29
00860008657329Halo Medical TechnologiesHMT-TRP2023-09-29
00860008657336Halo Medical TechnologiesHMT-TRP 3D2023-09-29
00860008657343Halo Medical TechnologiesHMT-MCP2023-09-29
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

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Primary DI, Brand, Company table
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