OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging System
FDA 510(k) K210458 · Abbott Medical
510(k) numberK210458
Submission
- Device name
- OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging System
- Applicant
- Abbott Medical
Westford, MA, US - Received
- February 16, 2021
- Decision date
- June 8, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NQQ – System, Imaging, Optical Coherence Tomography (Oct)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 892.1560
- Specialty
- Radiology
This device uses back-reflected light to create two-dimensional images versus back-reflected sound waves as are used in ultrasound imaging.
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| K253459 | OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System…NQQ · Traditional | 04/24/2026SE |
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Questions and answers
When was OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging System cleared by the FDA?
OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging System (K210458) received a 510(k) decision of Substantially Equivalent on June 8, 2021, 112 days after the submission was received.
What is the product code of K210458?
The FDA product code is NQQ – System, Imaging, Optical Coherence Tomography (Oct), a Class II (moderate risk) device regulated under 21 CFR 892.1560.