510(k) clearance
Align® Cover and Pad Guidance Tool
- 510(k) number
- K260114
- Applicant
- CIVCO Medical Instruments Co., Inc.
- Decision date
- Sep 24, 2026
- Date received
- Jan 14, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- ITX
- Device type
- Transducer, Ultrasonic, Diagnostic
- Device class
- Class II
- Regulation
- 21 CFR 892.1570
- Advisory committee
- Radiology
- Statement or summary
- Summary
- Third party
- N
- Location
- Coralville, IA, US