TECNOTOMO
FDA 510(k) clearance K790132 · decided 1979-02-21
Clearance details
- K-number
- K790132
- Device name
- TECNOTOMO
- Applicant
- Teknomed, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1979-01-23
- Decision date
- 1979-02-21
- Days to decision
- 29 days
- Clearance type
- Traditional
- Product code
- IZF
- Device class
- 2
- Regulation number
- 892.1740
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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| CLISIS SYSTEMS, Discovery RF180 (K213081) | General Medical Merate S.P.A | 2021-10-26 |
| DR 600 with Tomosynthesis (K193262) | Agfa N.V. | 2020-03-09 |
| DR 800 with Tomosynthesis (K183275) | Agfa N.V. | 2019-02-01 |
| DISCOVERY XR656 WITH VOLUMERAD (DIGITAL TOMOSYNTHESIS) (K132261) | Ge Medical Systems, LLC | 2013-11-18 |
| FUJIFILM TOMOSYNTHESIS OPTION FOR FDR ACSELERATE STATIONARY X-RAY SYSTEM (K121499) | Fujifilm Medical System U.S.A., Inc. | 2012-11-20 |
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Recalls involving this device
No recalls on record reference this clearance.