ES-Series
FDA 510(k) clearance K260589 · decided 2026-04-29
Clearance details
- K-number
- K260589
- Device name
- ES-Series
- Applicant
- E-Scopics
- Decision
- Substantially Equivalent
- Date received
- 2026-02-20
- Decision date
- 2026-04-29
- Days to decision
- 68 days
- Clearance type
- Special
- Product code
- IYN
- Device class
- 2
- Regulation number
- 892.1550
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Aix-En-Provence, FR
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.