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SonoScape BCC9-4

by Sonoscape Medical Corp.

SonoScape BCC9-4 is a rectal/vaginal ultrasound imaging transducer (FDA Class II) made by Sonoscape Medical Corp., cleared under FDA 510(k) K123616 on 21 Dec 2012 and listed in FDA GUDID since 19 Aug 2016 (UDI-DI 06945868601126), 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) K123616

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 Number06945868601126 UDI-DI Date19 Aug 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK123616 Date21 Dec 2012DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K123616 decided 21 Dec 2012 Active
  • FDA GUDID UDI-DI 06945868601126 listed 19 Aug 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K123616
  2. Listed FDA GUDID 06945868601126

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  • Withdrawn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/vaginal ultrasound imaging transducer
Model / reference
BCC9-4
Primary DI / UDI-DI
06945868601126
510(k) Number
FDA product code
IYO, ITX, IYN
GMDN term
Rectal/vaginal ultrasound imaging transducer
Device class
Class II
Regulation number
892.1560, 892.1570, 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 (K123616)

and 8 more cleared under K123616

Similar devices

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

Other devices from Sonoscape Medical Corp.

See all devices from Sonoscape Medical Corp. →

Properties

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