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Veuron-Brain-pAb2

by Heuron Co., Ltd.

510(k) K213801

Veuron-Brain-pAb2 is a medical device (FDA Class II; FDA product code LLZ, System, Image Processing, Radiological) made by Heuron Co., Ltd., cleared under FDA 510(k) K213801 on 4 Feb 2022 and listed in FDA GUDID since 18 Feb 2022 (UDI-DI 08800086200064), active as of 22 Oct 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 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number08800086200064 UDI-DI Date18 Feb 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK213801 Date4 Feb 2022ClearedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K213801 decided 4 Feb 2022 Active
  • FDA GUDID UDI-DI 08800086200064 listed 18 Feb 2022 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K213801
  2. Listed FDA GUDID 08800086200064

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k) · GUDID

Generic name
Radiology DICOM image processing application software
Model / reference
V-B-pAb-02
Primary DI / UDI-DI
08800086200064
510(k) Number
FDA product code
LLZ
GMDN term
Radiology DICOM image processing application software
Device class
Class II
Regulation
21 CFR Part 892.2050
Advisory committee
Radiology
FDA decision
SESE Substantially Equivalent
GUDID distribution status
In Commercial Distribution

Related clearances

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Devices cleared under K213801

1 device · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K213801
UDI-DISize and differences
Veuron-Brain-pAb2 V-B-pAb-02
Heuron Co., Ltd.
V-B-pAb-0208800086200064 —On the market

Similar devices

Other devices filed under FDA product code LLZ (System, Image Processing, Radiological).

Other devices from Heuron Co., Ltd.

See all devices from Heuron Co., Ltd. →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)