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SonoScape 6V1

by Sonoscape Medical Corp. 2 variants

SonoScape 6V1 is a Class II device made by Sonoscape Medical Corp., cleared under FDA 510(k) K112451 on 16 Sep 2011 and listed in FDA GUDID since 19 Aug 2016 (UDI-DI 06945868600280), 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

510(k) K112451

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06945868600280 UDI-DI Date19 Aug 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK112451 Date16 Sep 2011DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K112451 decided 16 Sep 2011 Active
  • FDA GUDID UDI-DI 06945868600280 listed 19 Aug 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K112451
  2. Listed FDA GUDID 06945868600280

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
SonoScape
Generic name
Rectal ultrasound imaging system transducer
Model / reference
6V1
Primary DI / UDI-DI
06945868600280
510(k) Number
FDA product code
ITX, IYO, IYN
GMDN term
Rectal ultrasound imaging system transducer
Device class
Class II
Regulation number
892.1570, 892.1560, 892.1550
GUDID distribution status
In Commercial Distribution

Related devices

Category: Rectal/vaginal ultrasound imaging transducerRectal ultrasound imaging system transducer

Cleared under the same submission (K112451)

and 8 more cleared under K112451

Similar devices

Other devices filed under FDA product code ITX (Transducer, Ultrasonic, Diagnostic).

Other devices from Sonoscape Medical Corp.

See all devices from Sonoscape Medical Corp. →

Properties

  • Prescription use
  • Serial number
Other properties (13, all answered No)