Skip to content

Rayvolve LN

by Azmed

510(k) K243831

Rayvolve LN is a medical device (FDA Class II; FDA product code MYN, Analyzer, Medical Image) made by Azmed, cleared under FDA 510(k) K243831 on 26 Mar 2025, active as of 11 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 11 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 11 Oct 2026.

Regulatory status

as of registry sync 11 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK243831 Date26 Mar 2025ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
MYN
Device class
Class II
Regulation
21 CFR Part 892.2070
Advisory committee
Radiology
FDA decision
SESE Substantially Equivalent

Similar devices

Other devices filed under FDA product code MYN (Analyzer, Medical Image).

Other devices from Azmed

  • Rayvolve 7

    Class II

  • Rayvolve

    Class IIa

  • Rayvolve AZchest

    Class II

  • Rayvolve PTX-PE

    Class II

See all devices from Azmed →