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Bladder Scanner

by Avantsonic Technology Co., Ltd.

510(k) K230986

Bladder Scanner is a medical device (FDA Class II; FDA product code IYO, System, Imaging, Pulsed Echo, Ultrasonic) made by Avantsonic Technology Co., Ltd., cleared under FDA 510(k) K230986 on 29 Dec 2023, active as of 22 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 22 Oct 2026

Documents

Trust

Unverified

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

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK230986 Date29 Dec 2023ClearedStatusActive

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  • Withdrawn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
IYO
Device class
Class II
Regulation
21 CFR Part 892.1560
Advisory committee
Radiology
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

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

Cites

Cited by

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

Devices cleared under K230986

2 devices · 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 K230986
UDI-DISize and differences
AVANTSONIC AS-1
Avantsonic Technology Co., Ltd.
AS-106971759810001 —On the market
AVANTSONIC AS-2
Avantsonic Technology Co., Ltd.
AS-206971759810032 —On the market

Similar devices

Other devices filed under FDA product code IYO (System, Imaging, Pulsed Echo, Ultrasonic).

Other devices from Avantsonic Technology Co., Ltd.