Medisono MUS05183

GUDID B369MUS05183

Medisono, LLC

General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system

• Primary Device ID: B369MUS05183
• NIH Device Record Key: da0adbd7-0eb1-4492-9167-80f66aaebe8b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Medisono
• Version Model Number: R7-A
• Catalog Number: MUS05183
• Company DUNS: 079686615
• Company Name: Medisono, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(305)406-3931
• Email: Fernando.ramon@medisono.com
• Phone: +1(305)406-3931
• Email: Fernando.ramon@medisono.com
• Phone: +1(305)406-3931
• Email: Fernando.ramon@medisono.com
• Phone: +1(305)406-3931
• Email: Fernando.ramon@medisono.com
• Phone: +1(305)406-3931
• Email: Fernando.ramon@medisono.com
• Phone: +1(305)406-3931
• Email: Fernando.ramon@medisono.com
• Phone: +1(305)406-3931
• Email: Fernando.ramon@medisono.com
• Phone: +1(305)406-3931
• Email: Fernando.ramon@medisono.com
• Phone: +1(305)406-3931
• Email: Fernando.ramon@medisono.com
• Phone: +1(305)406-3931
• Email: Fernando.ramon@medisono.com
• Phone: +1(305)406-3931
• Email: Fernando.ramon@medisono.com
• Phone: +1(305)406-3931
• Email: Fernando.ramon@medisono.com
• Phone: +1(305)406-3931
• Email: Fernando.ramon@medisono.com
• Phone: +1(305)406-3931
• Email: Fernando.ramon@medisono.com
• Phone: +1(305)406-3931
• Email: Fernando.ramon@medisono.com
• Phone: +1(305)406-3931
• Email: Fernando.ramon@medisono.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B369MUS05183 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131305

FDA Product Code

• ITX: Transducer, ultrasonic, diagnostic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-01-05
• Device Publish Date: 2020-12-28

On-Brand Devices [Medisono]

• B369MUS05185: P3-A
• B369MUS05184: MC3-A
• B369MUS05183: R7-A
• B369MUS05182: V6-A
• B369MUS05181: L7S-A
• B369MUS05179: MC6-A
• B369MUS05178: L7M-A
• B369MUS05177: C3-A
• B369MUS05176: PHASED ARRAY (SINGLE CRYSTAL) PROBE MODEL S1-5 FOR
• B369MUS05175: LINEAR ARRAY PROBE MODEL 12L-B FOR MEDISONO P25 EX
• B369MUS05174: LINEAR ARRAY PROBE PB-L742 FOR MEDISONO P11PLUS
• B369MUS05173: BIPLANE PROBE MODEL PB- BCL FOR MEDISONO P25 EXPER
• B369MUS05172: VOLUMETRIC ENDOCAVITY PROBE MODEL PB-VE9-5 FOR MED
• B369MUS05171: TRANSESOPHAGEAL MPTEE PROBE FOR MEDISONO P25 EXPER
• B369MUS05170: INTRAOPERATIVE MODEL PB-6CT-A FOR MEDISONO P25 EXP
• B369MUS05169: INTRAOPERATIVE PROBE MODEL PB-6CI-A FOR MEDISONO P
• B369MUS05168: LINEAR ARRAY (INTRAOPERATIVE) PROBE MODEL PB-12LT-
• B369MUS05167: LINEAR ARRAY (INTRAOPERATIVE) PROBE MODEL PB-10I2
• B369MUS05166: LINEAR ARRAY (INTRAOPERATIVE) PROBE MODEL PB-12LI-
• B369MUS05165: ENDOCAVITY ARRAY PROBE MODEL PB-6V3-A FOR MEDISONO
• B369MUS05164: ENDOCAVITY ARRAY PROBE MODEL MODEL: PB-6V7 FOR MED
• B369MUS05163: ENDOCAVITY ARRAY PROBE MODEL PB-6V1 FOR MEDISONO P
• B369MUS05162: PHASED ARRAY PROBE MODEL PB-7P-B FOR MEDISONO P25
• B369MUS05161: PHASED ARRAY PROBE MODEL PB-S1-5 FOR MEDISONO P25
• B369MUS05160: PHASED ARRAY PROBE MODEL PB-3P_A FOR MEDISONO P25
• B369MUS05159: CONVEX ARRAY PROBE MODEL PB-C613 FOR MEDISONO P25
• B369MUS05158: CONVEX ARRAY PROBE MODEL PB-C1-6 FOR MEDISONO P25
• B369MUS05157: LINEAR ARRAY PROBE MODEL PB-L752 FOR MEDISONO P25
• B369MUS05156: LINEAR ARRAY PROBE MODEL PB- 12L-B FOR MEDISONO P2
• B369MUS05155: LINEAR ARRAY PROBE MODEL PB- 12L-A FOR MEDISONO P2
• B369MUS05154: BIPLANE PROBE MODEL PB- BCC9-5 FOR MEDISONO P11 PL
• B369MUS05153: BIPLANE PROBE MODEL PB- BCL 10-5 FOR MEDISONO P11
• B369MUS05152: TRANSESOPHAGEAL MPTEE MINI PROBE FOR MEDISONO P11
• B369MUS05151: LAPAROSCOPE LINEAR ARRAY PROBE MODEL PB-LAP7 FOR M
• B369MUS05150: LINEAR ARRAY (INTRA-OPERATIVE) PROBE MODEL PB-10I2
• B369MUS05149: TRANSRECTAL ARRAY PROBE MODEL PB-EC9-5 (UROLOGY) F
• B369MUS05148: ENDOCAVITY ARRAY PROBE MODEL PB-6V1A FOR MEDISONO
• B369MUS05147: ENDOCAVITY ARRAY PROBE MODEL PB-6V7 FOR MEDISONO P
• B369MUS05146: ENDOCAVITY ARRAY MODEL PB-6V1 FOR MEDISONO P11 PLU
• B369MUS05145: MICRO-CONVEX ARRAY PB-C613 FOR MEDISONO P11 PLUS
• B369MUS05144: MICRO-CONVEX ARRAY PROBE MODEL PB-C611 FOR MEDISON
• B369MUS05143: CONVEX ARRAY MODEL PB-C322 FOR MEDISONO P11 PLUS
• B369MUS05142: CONVEX ARRAY MODEL PB-C353 FOR MEDISONO P11 PLUS
• B369MUS05141: CONVEX ARRAY PROBE MODEL PB-C354 FOR MEDISONO P11
• B369MUS05140: LINEAR PROBE MODEL PB-L741 FOR MEDISONO P25 EXPERT
• B369MUS05139: PHASED ARRARY MODEL PB-5P1 FOR MEDISONO P11 PLUS
• B369MUS05138: CONVEX VOLUMETRIC PROBE MODEL PB-VC6-2 FOR MEDISON
• B369MUS05137: CONVEX PROBE MODEL PB-3C-A FOR MEDISONO P25 EXPERT
• B369MUS05136: ENDOCAVITARY PROBE MODEL PB-6V3 FOR MEDISONO P25 E
• B369MUS05135: LINEAR PROBE MODEL PB-L742 FOR MEDISONO P25 EXPERT