FDA 510(k)

S90 Exp Series Digital Color Doppler Ultrasound System

Numéro K : K222596 · 2023-02-10

Date de décision2023-02-10

Code produitIYN

Comité consultatifRA

DécisionSubstantially Equivalent

Résumé du dispositif

S90 Exp Series Digital Color Doppler Ultrasound System is the device name listed in this FDA 510(k) record. The listed applicant is Sonoscape Medical Corp.. It received FDA 510(k) clearance on 2023-02-10 under 510(k) number K222596. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the S90 Exp Series Digital Color Doppler Ultrasound System?

S90 Exp Series Digital Color Doppler Ultrasound System is a medical device that received FDA 510(k) clearance on 2023-02-10. The listed applicant is Sonoscape Medical Corp.. The 510(k) number is K222596.

When did S90 Exp Series Digital Color Doppler Ultrasound System receive FDA 510(k) clearance?

S90 Exp Series Digital Color Doppler Ultrasound System received FDA 510(k) clearance on 2023-02-10, under 510(k) number K222596.

Who is the listed applicant for S90 Exp Series Digital Color Doppler Ultrasound System?

The FDA 510(k) record lists Sonoscape Medical Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for S90 Exp Series Digital Color Doppler Ultrasound System?

The FDA product code for S90 Exp Series Digital Color Doppler Ultrasound System is IYN.

Essais cliniques associés

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Autres dossiers indiquant Sonoscape Medical Corp. en tant que demandeur

K254027Digital Color Doppler Ultrasound System (Marvo 95/Marvo 95 Elite/Marvo 90/Marvo 90 CV/Marvo 90 Pro/Marvo 90 Exp/Marvo 90 Elite/Marvo Expert/Marvo 85/Marvo 85 Pro/Marvo 85 Exp/Marvo 85 Elite/Marvo Senior/Marvo 75 Elite/Marvo 75i/Fenix 95/Fenix 95 Elite/Fenix 90/Fenix 90 Elite/Fenix Expert/Fenix 85/Fenix 85 Elite/Fenix Senior/Fenix 75 Elite/Fenix 75i/Endo 80/Endo 90)K254028Digital Color Doppler Ultrasound System (Autra RS, Autra 90, Autra Senior, Autra CV, e-Autra, Autra 75, Autra 85W, Autra 65, Autra 55, Autra 65i, Autra 90 Elite, Autra 85 Elite, Autra 80 Elite, Autra 75 Elite, Autra 85 CV, Autra 80W, Autra 65 Elite, Autra 55 Elite, Autra 55i, Autra 90 CV, Autra 85, Autra 80, Autra 80 CV, Autra 75 Pro, Autra 75W, Autra 70 Elite, Autra 70, Autra T)K252498Digital Color Doppler Ultrasound System (X11 Exp/X11 Elite/X11 Pro/X11 Plus/X11 Super/X11 Senior/X11/E11/E11 Pro/E11 Plus/E11 Elite/X11T/X11U/X11R/X11i/X11s/E11T/E11i/E11s/XR1/XR2/ XR3/ER1/ER2/ER3/X10 Exp/X10 Elite/X10 Pro/X10 Plus/X10 Super/X10 Senior/X10/X10T/X10U/ X10R/X10i/X10s/E10/E10 Pro/E10 Plus/E10T/E10i/E10s/SU11A EXP/SU11A PRO/SU11A AD/ SU11A CU/SU11B EXP/SU11B PRO/SU11B AD/SU11B CU/SU11C EXP/SU11C PRO/SU11C AD/ SU11C CU)K241949Digital Color Doppler Ultrasound System (P60 Series)K231813Ultrasonic Gastrovideoscope K221089P12 Elite Series Digital Color Doppler Ultrasound System

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Dispositifs connexes (Code : IYN)

Source officielle

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