Tigerview Professional
510(k) K061035
Tigerview Professional is a Class II device made by Televere Systems, cleared under FDA 510(k) K061035 on 5 Jun 2006, 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 | FDA 510(k)SESE | NumberK061035 | Date5 Jun 2006 | StatusActive |
Official records
- FDA 510(k) database K061035
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- Withdrawn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
Devices cleared under K061035
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| ExamVue PACS 1.1 Build 81 | ExamVue PACS 1.1 Build 81 / 1.1 Build 81 | 00851800007078 | — | On the market |
| TigerView 7.7.13 | TigerView Pro 7.7.13 / 7.7.13 | 00851800007009 | — | On the market |
| TigerView 7.7.3 | TigerView Pro 7.7.3 / 7.7.3 | 00851800007023 | — | On the market |
| TigerView 8.1 Build 81 | TigerView 8.1 Build 81 / 8.1 Build 81 | 00851800007016 | — | On the market |
| TigerView 8.2 | TigerView 8.2 / 8.2 | 00851800007085 | — | On the market |
| TigerView 8.3 | TigerView 8.3 / 8.3 | 00851800007061 | — | On the market |
| TigerView 8.4.1 | TigerView 8.4.1 / 8.4.1 | 00851800007108 | — | On the market |
| TigerView 8.6 | TigerView 8.6 / 8.6 | 00851800007139 | — | On the market |
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Other devices filed under FDA product code LLZ (System, Image Processing, Radiological).
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