Teratech Model 10V5 Smart Probe
510(k) K040840
Teratech Model 10V5 Smart Probe is a medical device (FDA Class II; FDA product code ITX, Transducer, Ultrasonic, Diagnostic) made by Teratech Corp., cleared under FDA 510(k) K040840 on 14 Apr 2004, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK040840 | Date14 Apr 2004 | StatusActive |
Official records
- FDA 510(k) database K040840
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- ITX
- Device class
- Class II
- Regulation
- 21 CFR Part 892.1570
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
Similar devices
Other devices filed under FDA product code ITX (Transducer, Ultrasonic, Diagnostic).
- EUP-C321 5.0MHZ CONVEX TYPE PROBE by Hitachi Medical Corp. of America
- 2D Abdominal Probe K2DAB00 by KOELIS
- Sheathes (Non-Latex), Sterile by Sheathing Technologies, Inc.
- Flying Diagnostic Ultrasound System by Neusoft Medical Systems Co., Ltd.
- Ausonics Opus 1 System, Annular Array Option by Ausonics Pty, Ltd.
- UNBRANDED 20-P3D696 by Advance Medical Designs, Inc.
- EMM Ultrasonic Transducer Cover by Exact Medical Manufacturing
- 16L4 Transducer 11284846 by SIEMENS MEDICAL SOLUTIONS USA, INC.
- A-View by Stroke2Prevent
- Sector Probe S4-2 A7CA by KONICA MINOLTA, INC.