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510(k) Data Aggregation
K Number
K040926Device Name
ULTRASOUND SCANNER, HUDSON MODELS 8000 AND 9000
Manufacturer
HUDSON DIAGNOSTIC IMAGING LLC
Date Cleared
2004-06-10
(63 days)
Product Code
IYN, ITX, IYO
Regulation Number
892.1550Why did this record match?
Applicant Name (Manufacturer) :
HUDSON DIAGNOSTIC IMAGING LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: High resolution ultrasound imaging of wounds.
Device Description
The Hudson 8000 & 9000 Imaging Systems are diagnostic ultrasound scanners which incorporates a proprietary method of imaging wounds both cavernous and non-cavernous types. The ultrasound scanners use linear array transducers (5-10 Mhz). The scanners are capable of imaging wounds including pressure ulcers which may invade and penetrate tissues as much as 6 cm in some areas of the body.
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K Number
K022928Device Name
HUDSON 2020, 2040, 2060,ULTRASOUND SCANNERS
Manufacturer
HUDSON DIAGNOSTIC IMAGING LLC
Date Cleared
2002-12-11
(98 days)
Product Code
IYO
Regulation Number
892.1560Why did this record match?
Applicant Name (Manufacturer) :
HUDSON DIAGNOSTIC IMAGING LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
High resolution ultrasound imaging of wounds such as:
- Clean, closed surgical incisions
- Skin graft donor sites
- Superficial wounds such as abrasion, skin tears, and blisters
- Chafed skin or irritated skin
- Ulcers-cavernous and non-cavernous
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application: Wounds, Mode of Operation: B
Device Description
Not Found
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