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510(k) Data Aggregation
K Number
K070845Device Name
SOUNMED COLOPOSCOPE COLPO-99/99PLUS
Manufacturer
SOUNMED, INC.
Date Cleared
2007-10-12
(199 days)
Product Code
HEX
Regulation Number
884.1630Why did this record match?
Applicant Name (Manufacturer) :
SOUNMED, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Sounmed Colposcope COLPO-99 is intended to permit direct viewing of the tissues of the vagina and cervix by a telescopic system located outside the vagina. It is used to diagnose abnormalities and select areas for biopsy.
Device Description
The ColposcopeS COLPO-99 / 99 PLUS is a precise optical instrument designed specially for the gynecologic examination. The Sounmed colposcope can be used to view vaginal en cervical tissues using stereoscopic optics. The COLPO-99/ 99 PLUS Colposcope has detailed features that include a wide field of view, long focal length, uniform illumination, adjustable brightness, ease operation, and exceptional optics. It is an essential instrument for any gynecologic examination. The general features of the device are as follows: Eyepiece Magnification: 12.5X with diopter adjustment. Focal Length: 300mm. Green filter light. Easy replacement of halogen light bulb. Ball joint gives you 360 degree easy motion for gross focus.
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K Number
K071156Device Name
SOUNMED SD-2000 PLUS PORTABLE ULTRASOUND SCANNER
Manufacturer
SOUNMED, INC.
Date Cleared
2007-07-03
(69 days)
Product Code
IYO
Regulation Number
892.1560Why did this record match?
Applicant Name (Manufacturer) :
SOUNMED, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Diagnostic ultrasound imaging or fluid flowd analyisis of the human body as follows:
- Fetal-OB/GYN
- Abdominal
- Small Organs (breast, thyroid, testicle)
- Trans-Vaqinal
- Trans-Rectal
Typical examinations performed using the system are:
- General abdominal and pelvic studies including organ surveys, assessment, and retroperitoneal cavity studies.
- Study of small parts and superficial structures including breasts, shoulders, thyroid, and the abdominal wall.
- First, second and third trimester pregnancy studies.
- Prostate, bladder and rectum visualization.
Device Description
The Sounmed SD-2000 Plus (KX2000G) is a black and white mobile diagnostic ultrasound imaging system. This device is designed to project ultrasound waves into body tissue and to present the returned echo information on the monitor. Operating Modes of SD-2000 Plus (KX2000G) are B, B/B, B/M, and M. The Sounmed SD-2000 Plus (KX2000G) supports a selection of Linear and Convex probes for wide variety of application. It is an ultrasound scanner, which provides high resolution, high penetration, and various measurement functions. Probes are supported in frequencies from 3.5 MHz to 7.5 MHz.
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