Lifesys Pacs 2
by Lifetrack Medical Systems, Inc.
Lifesys Pacs 2 is a radiological PACS-dedicated management software (FDA Class II; FDA product code LLZ, System, Image Processing, Radiological) made by Lifetrack Medical Systems, Inc., cleared under FDA 510(k) K161341 on 5 Apr 2017 and listed in FDA GUDID since 13 Jul 2017 (UDI-DI B581LIFESYSPACSV20), 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 | NumberB581LIFESYSPACSV20 | Date13 Jul 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK161341 | Date5 Apr 2017 | StatusActive |
Official records
- FDA 510(k) database K161341
Across registries
- FDA 510(k) K161341 decided 5 Apr 2017 Active
- FDA GUDID UDI-DI B581LIFESYSPACSV20 listed 13 Jul 2017 Listed
Timeline
- Cleared FDA 510(k) K161341
- Listed FDA GUDID B581LIFESYSPACSV20
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Lifesys Pacs
- Generic name
- Radiological PACS-dedicated management software
- Model / reference
- 2
- Primary DI / UDI-DI
- B581LIFESYSPACSV20
- 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
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