SonoScape

GUDID 06945868603083

10I2 Ultrasonic Transducer (X5 Series)

SONOSCAPE MEDICAL CORP.

Extracorporeal ultrasound imaging transducer, hand-held

• Primary Device ID: 06945868603083
• NIH Device Record Key: 040b3046-6fe3-42c4-b46b-0eb6fea81abd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SonoScape
• Version Model Number: 10I2
• Company DUNS: 545342185
• Company Name: SONOSCAPE MEDICAL CORP.
• 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: false
• Serial Number: true
• Manufacturing Date: false
• 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	06945868603083 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182648

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: 2019-04-09
• Device Publish Date: 2019-04-01

On-Brand Devices [SonoScape]

• 06945868699055: S9 Pro Portable Digital Color Doppler Ultrasound System (With 3P1 and L742 Transducers)
• 06945868699048: S8 Exp Portable Digital Color Doppler Ultrasound System (With 3C-A and L741 Transducers)
• 06945868699031: S9 Portable Digital Color Doppler Ultrasound System (With 4P-A and L742 Transducers)
• 06945868699024: S9 Pro Portable Digital Color Doppler Ultrasound System
• 06945868699017: S8 Exp Portable Digital Color Doppler Ultrasound System
• 06945868698010: S8 Diagnostic Ultrasound System (With C362 and L742 Transducers)
• 06945868698003: S8 Diagnostic Ultrasound System
• 06945868696016: S6 Diagnostic Ultrasound System (With L741 and C344 Transducers)
• 06945868696009: S6 Diagnostic Ultrasound System
• 06945868695040: E5 Pro Series Digital Color Doppler Ultrasound System
• 06945868695033: E5 Exp Series Digital Color Doppler Ultrasound System
• 06945868695026: E1 Series Digital Color Doppler Ultrasound System
• 06945868695019: E5 Series Digital Color Doppler Ultrasound System
• 06945868695002: X5 Digital Color Doppler Ultrasound System
• 06945868693060: X3 Pro Digital Color Doppler Ultrasound System
• 06945868693053: X3 Exp Digital Color Doppler Ultrasound System
• 06945868693046: X3 Digital Color Doppler Ultrasound System
• 06945868693039: E3 Pro Series Digital Color Doppler Ultrasound System
• 06945868693022: E3 Series Digital Color Doppler Ultrasound System
• 06945868693015: E3 Exp Series Digital Color Doppler Ultrasound System
• 06945868692025: E2 Series Digital Color Doppler Ultrasound System
• 06945868692018: E2 Pro Series Digital Color Doppler Ultrasound System
• 06945868692001: E2 Exp Series Digital Color Doppler Ultrasound System
• 06945868691035: X1 Pro Digital Color Doppler Ultrasound System
• 06945868691028: X1 Digital Color Doppler Ultrasound System
• 06945868691011: E1 Pro Series Digital Color Doppler Ultrasound System
• 06945868691004: E1 Exp Series Digital Color Doppler Ultrasound System
• 06945868680015: SSI-8000 Mobile Digital Color Doppler Ultrasound System (With C362 and L743 Transducers)
• 06945868680008: SSI-8000 Mobile Digital Color Doppler Ultrasound System
• 06945868622091: C613 Ultrasonic Transducer (E5)
• 06945868620141: 3P-A Ultrasonic Transducer (E5)
• 06945868620134: 6V1 Ultrasonic Transducer (E5)
• 06945868616106: S60 Maso Digital Color Doppler Ultrasound System
• 06945868616090: S60 VO Digital Color Doppler Ultrasound System
• 06945868616083: S60 Pro Digital Color Doppler Ultrasound System
• 06945868616076: S60 Exp Digital Color Doppler Ultrasound System
• 06945868616069: S60 Digital Color Doppler Ultrasound System
• 06945868616052: P60 Exp Series Digital Color Doppler Ultrasound System
• 06945868616045: P60 Pro Series Digital Color Doppler Ultrasound System
• 06945868616038: P60 CV Series Digital Color Doppler Ultrasound System
• 06945868616021: P60 Series Digital Color Doppler Ultrasound System
• 06945868616014: A6 Portable Ultrasonic Diagnostic System (With C351 Transducer)
• 06945868616007: A6 Portable Ultrasonic Diagnostic System
• 06945868615901: S59 Digital Color Doppler Ultrasound System
• 06945868615055: P50 S Series Digital Color Doppler Ultrasound System
• 06945868615048: P50 Exp Series Digital Color Doppler Ultrasound System
• 06945868615031: P50 Pro Series Digital Color Doppler Ultrasound System
• 06945868615024: P50 Series Digital Color Doppler Ultrasound System
• 06945868615017: S50 Digital Color Doppler Ultrasound System (With 3C-A and 6V3 Transducers)
• 06945868615000: S50 Digital Color Doppler Ultrasound System