ImaCor Zura Handheld ZHH-010
FDA 510(k) clearance K220490 · decided 2022-04-08
Clearance details
- K-number
- K220490
- Device name
- ImaCor Zura Handheld ZHH-010
- Applicant
- Imacor, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2022-02-22
- Decision date
- 2022-04-08
- Days to decision
- 45 days
- Clearance type
- Traditional
- Product code
- IYN
- Device class
- 2
- Regulation number
- 892.1550
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Jericho, NY, US
- Third-party review
- Yes
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Imacor
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ClariTEE Miniaturized TEE probe. Model Number: CLT-010. Ultrasound miniaturized TEE probe recall (Z-0038-2026) | ImaCor Inc. | 2025-10-03 |
| ClariTEE Probe- Miniature transesophageal echo ultrasound probe for use with ImaCor ultras recall (Z-0231-2025) | ImaCor Inc. | 2024-10-25 |