FDA 510(k) Premarket Notification K253459: OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001)

Submission Details & Decision

Normalized public record details for 510(k) notification K253459.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K253459

Applicant / Sponsor

ABBOTT MEDICAL

Device Name

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

Product Code

NQQ

Decision Date

2026-04-24

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Radiology (RA)

Clearance Type

Traditional

Third Party Flag

Date Received

2025-10-07

Related Establishments / Registrations

ISOMEDIX OPERATIONS INC. Registration: 1220477 View Registration
J-PAC, LLC. Registration: 1221051 View Registration
ABBOTT VASCULAR Registration: 2024168 View Registration
PARTER MEDICAL PRODUCTS, INC. Registration: 2024311 View Registration
Isomedix Operations, Inc. Registration: 2030624 View Registration
ISOMEDIX OPERATIONS INC. Registration: 2245304 View Registration
Isomedix Operations Inc. Registration: 2246552 View Registration
Abbott Vascular Netherlands Registration: 3004091615 View Registration
Micro-Tech (Nanjing) Co., Ltd. Registration: 3004837686 View Registration
TERUMO CARDIOVASCULAR SYSTEMS THI PLANT Registration: 3005228872 View Registration
MICHELSON DIAGNOSTICS LTD Registration: 3007603861 View Registration
Abbott Medical Registration: 3009600098 View Registration
Synergy Health AST, LLC Registration: 3009882464 View Registration
RBC Development LLC dba RBC Medical Innovations dba Vantage MedTech Registration: 3010126772 View Registration
GENTUITY, LLC Registration: 3011578544 View Registration
St. Jude Medical Registration: 3012179728 View Registration
Conavi Medical Inc Registration: 3012198618 View Registration
PERIMETER MEDICAL IMAGING AI, INC. Registration: 3013276158 View Registration
SHENZHEN VIVOLIGHT MEDICAL DEVICE&TECHNOLOGY CO., LTD. Registration: 3013351723 View Registration
Micro-Tech (Nanjing) Co., Ltd. Registration: 3013440400 View Registration
SPECTRAWAVE, INC. Registration: 3017654247 View Registration
GENTUITY, LLC Registration: 3021630097 View Registration
DAMAE MEDICAL Registration: 3027259266 View Registration
ZYLOX-TONBRIDGE MEDICAL TECHNOLOGY CO., LTD. Registration: 3038165043 View Registration
OPXION TECH. INCORPORATION Registration: 3042929028 View Registration
LEADOPTIK INC. Registration: 3042970803 View Registration
RBC Development LLC dba RBC Medical Innovations dba Vantage MedTech Registration: 3043527620 View Registration

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