Omni Legend
FDA 510(k) clearance K241665 · decided 2024-08-08
Clearance details
- K-number
- K241665
- Device name
- Omni Legend
- Applicant
- Ge Medical Systems Israel, Functional Imaging
- Decision
- Substantially Equivalent
- Date received
- 2024-06-10
- Decision date
- 2024-08-08
- Days to decision
- 59 days
- Clearance type
- Traditional
- Product code
- KPS
- Device class
- 2
- Regulation number
- 892.1200
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Tirat Hacarmel, IL
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Ge Medical Systems Israel
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 |
|---|---|---|
| GE Healthcare Omni Legend, sold under the following names: OMNI Legend 16, Omni Legend 21, recall (Z-1112-2026) | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING | 2026-01-16 |