Regulatory filing

K232808 (us_fda)

FDA 510(k) K232808 for Butterfly iQ3 Ultrasound System (also covers iQ/iQ+). Portable handheld POCUS. Original iQ cleared 2018.

fda 510k · cleared · decided 2023-01-01

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Key facts

Jurisdiction: us_fda
Filing type: fda 510k
Status: cleared
Filing number: K232808
Filing date: 2023-01-01
Decision date: 2023-01-01
Verification posture: verified

Applicant

Butterfly Network

Covered models (1)

Butterfly iQ+

Sources (1)

https://www.accessdata.fda.gov/cdrh_docs/pdf23/K232808.pdf

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Identity

b0a70caf-648f-49e4-9bfb-057bd32e4a04