Target CAT#B7850AA & B7850AB & B7850B
FDA 510(k) K851301 · General Electric Co.
510(k) numberK851301
Submission
- Device name
- Target CAT#B7850AA & B7850AB & B7850B
- Applicant
- General Electric Co.
Milwaukee, WI, US - Received
- April 1, 1985
- Decision date
- September 20, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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|---|---|---|---|
| K260174 | Probeat-CrLHN · Traditional | Hitachi High-Tech Corp. | 06/11/2026SE |
| K252815 | ProBeam 360 Proton Therapy System v3.0LHN · Traditional | Varian Medical Systems, Inc. | 04/23/2026SE |
| K253406 | S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)LHN · Traditional | Mevion Medical Systems, Inc. | 03/25/2026SE |
| K250986 | S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)LHN · Traditional | Mevion Medical Systems, Inc. | 09/12/2025SE |
| K243900 | eMotus Respiratory Motion Management SystemLHN · Traditional | Empnia, Inc. | 06/27/2025SE |
| K242418 | P-Cure Proton Therapy System (PPTS)LHN · Traditional | P-Cure, Ltd. | 05/12/2025SE |
| K232032 | Probeat-FrLHN · Traditional | Hitachi, Ltd. Radiation Oncology Systems… | 01/12/2024SE |
| K231863 | ProBeam 360° Proton Therapy System v2.0 (Multiroom)LHN · Traditional | Varian Medical Systems, Inc. | 10/06/2023SE |
| K221996 | P-Cure Proton Beam Therapy SystemLHN · Traditional | P-Cure, Ltd. | 03/20/2023SE |
| K220883 | Small Field ApplicatorLHN · Traditional | Hitachi, Ltd. Radiation Oncology Systems… | 12/15/2022SE |
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| K082317 | GE Lunar Frax 10-YEAR Fracture Risk Software OptionKGI · Traditional | 09/26/2008SE |
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| K073297 | GE Logiq P6IYN · Special | 12/18/2007SE |
| K072952 | GE EchopacLLZ · Special | 11/16/2007SE |
| K072797 | GE Logiq I Comapact Ultrasound, GE Logiq E Compact Ultrasound, GE Vivid E Compact…IYO · Special | 10/17/2007SE |
| K072075 | Modification to GE Logiq A3IYN · Special | 08/29/2007SE |
| K071985 | GE Vivid S5 and S6 Diagnostic UltrasoundIYN · Special | 08/17/2007SE |
Questions and answers
When was Target CAT#B7850AA & B7850AB & B7850B cleared by the FDA?
Target CAT#B7850AA & B7850AB & B7850B (K851301) received a 510(k) decision of Substantially Equivalent on September 20, 1985, 172 days after the submission was received.
What is the product code of K851301?
The FDA product code is LHN – System, Radiation Therapy, Charged-Particle, Medical, a Class II (moderate risk) device regulated under 21 CFR 892.5050.