Voluson 5954291

GUDID 00195278814685

VolusonExp BT24 to BT25 UPG

GE Healthcare Austria GmbH & Co OG

General-purpose ultrasound imaging system

• Primary Device ID: 00195278814685
• NIH Device Record Key: 27484fac-67bc-4068-94f6-268b14163142
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Voluson
• Version Model Number: Exp BT24 to BT25 UPG
• Catalog Number: 5954291
• Company DUNS: 300599979
• Company Name: GE Healthcare Austria GmbH & Co OG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00195278814685 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K242168

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: 2025-01-16
• Device Publish Date: 2025-01-08

On-Brand Devices [Voluson]

• 00840682145411: E BT19 to BT20 UPG
• 00840682144353: E10 BT20
• 00840682144346: VE8 BT20
• 00840682144339: E6 BT20
• 00840682142588: E BT17 to BT19 UPG
• 00840682139533: E BT18 to BT19 UPG
• 00840682139168: VE8 BT19
• 00840682139151: E10 BT19
• 00840682139144: E6 BT19
• 00840682123945: E8 BT18
• 00840682123938: E10 BT18
• 00840682123907: E6 BT18
• 00840682123891: E BT17 to BT18 UPG
• 00840682120661: E BT16 to BT17 UPG
• 00840682120197: E BT15 to BT17 UPG
• 00840682119672: ie all BTs to BT14 UPG
• 00840682118712: E BT10 to BT13 UPG
• 00840682118705: E BT15 to BT16 UPG
• 00840682118675: E BT12 to BT13 UPG
• 00840682117951: E10 BT17
• 00840682117944: E8 BT17
• 00840682117937: E6 BT17
• 00840682100144: E10 BT16
• 00840682100137: E8 BT16
• 00840682100120: E6 BT16
• 00195278077592: E BT20 to BT21 UPG
• 00195278016836: E6 BT21
• 00195278016829: E8 BT21
• 00195278016812: E10 BT21
• 00195278347497: Voluson Expert 22
• 00195278347480: Voluson Expert 20
• 00195278347473: Voluson Expert 18
• 00195278699824: Voluson Expert 20 BT24
• 00195278699800: Voluson Expert 18 BT24
• 00195278699848: Voluson Expert 22 BT24
• 00195278677587: Voluson Exp to BT24 UPG
• 00195278770271: Voluson Expert 22 BT25
• 00195278770226: Voluson Expert 18 BT25
• 00195278770158: Voluson Expert 20 BT25
• 00195278814685: VolusonExp BT24 to BT25 UPG