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Rayvolve 7

by Azmed 3 variants

Rayvolve 7 is a basic x-ray clinical assessment support software (FDA Class II; FDA product code QBS, Radiological Computer Assisted Detection/Diagnosis Software For Fracture) made by Azmed, cleared under FDA 510(k) K261378 on 28 Aug 2026 and listed in FDA GUDID since 22 Oct 2026 (UDI-DI 03770018071206), active as of 2 Nov 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 2 Nov 2026

Documents

510(k) K261378

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 2 Nov 2026.

Regulatory status

as of registry sync 2 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number03770018071206 UDI-DI Date22 Oct 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK261378 Date28 Aug 2026DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K261378 decided 28 Aug 2026 Active
  • FDA GUDID UDI-DI 03770018071206 listed 22 Oct 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K261378
  2. Listed FDA GUDID 03770018071206

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Rayvolve
Generic name
Basic x-ray clinical assessment support software
Model / reference
7
Primary DI / UDI-DI
03770018071206
510(k) Number
FDA product code
QBS
GMDN term
Basic x-ray clinical assessment support software
Device class
Class II
Regulation number
892.2090
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K261378)

Similar devices

Other devices filed under FDA product code QBS (Radiological Computer Assisted Detection/Diagnosis Software For Fracture).

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 →

Properties

  • Lot / batch number
  • Manufacturing date
Other properties (13, all answered No)