eRAD PACS 7.3
by Erad, Inc.
eRAD PACS 7.3 is a Class II device made by Erad, Inc., cleared under FDA 510(k) K120995 on 3 Dec 2012 and listed in FDA GUDID since 2 May 2016 (UDI-DI 00866994000217), active as of 22 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 | Number00866994000217 | Date2 May 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK120995 | Date3 Dec 2012 | StatusActive |
Official records
- AccessGUDID record 00866994000217
- FDA 510(k) database K120995
Across registries
- FDA 510(k) K120995 decided 3 Dec 2012 Active
- FDA GUDID UDI-DI 00866994000217 listed 2 May 2016 Listed
Timeline
- Cleared FDA 510(k) K120995
- Listed FDA GUDID 00866994000217
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- eRAD PACS
- Generic name
- Radiological PACS-dedicated management software
- Model / reference
- 7.3
- Primary DI / UDI-DI
- 00866994000217
- 510(k) Number
- FDA product code
- LLZ
- GMDN term
- Radiological PACS-dedicated management software
- Device class
- Class II
- Regulation number
- 892.2050
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Radiological PACS software.
- McKesson Radiology 12.3 by Change Healthcare Canada Company
- INFINITT Cardiology PACS by INFINITT Healthcare Co., Ltd.
- Change Healthcare Radiology Solutions 14.0 by Change Healthcare Canada Company
- INFINITT RT PACS by INFINITT Healthcare Co., Ltd.
- Visage Ease Pro 2.2 by Visage Imaging, Inc.
- Vitrea Software Package VSTP-002A by CANON INC.
- Sidexis 4 6773258 by SIRONA Dental Systems GmbH
- ContourProtégéAI - CT Thorax 1.0 by MIM SOFTWARE INC.