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Computer (Industrial) FPRCO00011

by Uc-Care Ltd

Computer (Industrial) FPRCO00011 is a rectal ultrasound navigational image processor (FDA Class II; FDA product code LLZ, System, Image Processing, Radiological) made by Uc-Care Ltd, cleared under FDA 510(k) K100784 on 1 Nov 2011 and listed in FDA GUDID since 15 Nov 2017 (UDI-DI 07290016936018), active as of 23 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 23 Oct 2026

Documents

510(k) K100784

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number07290016936018 UDI-DI Date15 Nov 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK100784 Date1 Nov 2011DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K100784 decided 1 Nov 2011 Active
  • FDA GUDID UDI-DI 07290016936018 listed 15 Nov 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K100784
  2. Listed FDA GUDID 07290016936018

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Computer (Industrial)
Generic name
Rectal ultrasound navigational image processor
Model / Ref / Catalog
FPRCO00011
Primary DI / UDI-DI
07290016936018
510(k) Number
FDA product code
LLZ
GMDN term
Rectal ultrasound navigational image processor
Device class
Class II
Regulation number
892.2050
GUDID distribution status
In Commercial Distribution

Related devices

Category: Rectal ultrasound navigational image processor

Cleared under the same submission (K100784)

and 8 more cleared under K100784

Similar devices

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

Other devices from Uc-Care Ltd

See all devices from Uc-Care Ltd →

Properties

  • Serial number
Other properties (14, all answered No)