Roll Stand + Arm HRDGN00023
by Uc-Care Ltd
Roll Stand + Arm HRDGN00023 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 07290016936117), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number07290016936117 | Date15 Nov 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK100784 | Date1 Nov 2011 | StatusActive |
Official records
- AccessGUDID record 07290016936117
- FDA 510(k) database K100784
Across registries
- FDA 510(k) K100784 decided 1 Nov 2011 Active
- FDA GUDID UDI-DI 07290016936117 listed 15 Nov 2017 Listed
Timeline
- Cleared FDA 510(k) K100784
- Listed FDA GUDID 07290016936117
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Roll Stand + Arm
- Generic name
- Rectal ultrasound navigational image processor
- Model / Ref / Catalog
- HRDGN00023
- Primary DI / UDI-DI
- 07290016936117
- 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
Similar devices
Other devices filed under FDA product code LLZ (System, Image Processing, Radiological).
- SIMPLANT IMMEDIATE SMILE DENTAL CARE SYSTEM by Materialise Dental NV
- PERSONAL DISPLAY SYSTEM by Vortech Data, Inc.
- TRIANA, PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM by GENORAY CO., LTD.
- MIM - SPECTRA Quant by MIM SOFTWARE INC.
- eUnity by Client Outlook, Inc.
- NIO 5MP-21 AND MDNG-5121 CB by Barcoview
- EFAI PACS Picture Archiving and Communication System by Ever Fortune.Ai, Co., Ltd.
- IMPAX CLIENT EMBRACE by Agfa Corp.
- BARCOVIEW MGD 521M DIGITAL MAMMOGRAPHY DISPLAY by Barco NV Barcoview
- COMPACS, VERSION 1.0 by Intelligent Images Srl