Art Lab Software
by Pie Medical
510(k) K061961
Active
510(k)
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK061961 | Date6 Sep 2006 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- LLZ
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.2050
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 23 Sep 2026
The Art Lab Software is a type of software used in radiology. It is described as substantially equivalent, indicating its similarity to existing devices. The software is used for unspecified purposes in the field of radiology.
The Art Lab Software is supplied by Pie Medical and has received FDA 510K authorization. It is classified under the product code LLZ and has been reviewed by the Radiology advisory committee. The software is associated with the k number K061961.