Atlas FDA

OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001)

FDA 510(k) clearance K253459 · decided 2026-04-24

Clearance details

K-number
K253459
Device name
OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001)
Applicant
ABBOTT MEDICAL
Decision
Substantially Equivalent
Date received
2025-10-07
Decision date
2026-04-24
Days to decision
199 days
Clearance type
Traditional
Product code
NQQ
Device class
2
Regulation number
892.1560
Medical specialty
Radiology
Advisory committee
Radiology
Location
Westford, MA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.

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