TCT-300S Computed Tomo. (CT) X-Ray System for Exam
FDA 510(k) K881305 · Toshiba Medical Systems
510(k) numberK881305
Submission
- Device name
- TCT-300S Computed Tomo. (CT) X-Ray System for Exam
- Applicant
- Toshiba Medical Systems
Tustin, CA, US - Received
- March 28, 1988
- Decision date
- October 19, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code JAK
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|---|---|---|---|
| K253836 | FCT iStream Phase 2JAK · Traditional | Fujifilm Corporation | 09/04/2026SE |
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| K253026 | Respiratory Gating for Scanners (2.1)JAK · Traditional | Varian Medical Systems, Inc. | 06/04/2026SE |
| K253596 | Aquilion ONE (TSX-308A/TSX-306A) V2.0JAK · Traditional | Canon Medical Systems Corporation | 05/20/2026SE |
| K253649 | Spectral CT Verida FamilyJAK · Traditional | Philips Medical Systems Technologies , Ltd. | 03/27/2026SE |
| K253686 | True Definition DLJAK · Traditional | Ge Healthcare Japan Corporation | 03/23/2026SE |
| K252992 | CT Rembra RT; CT Areta RT; CT RembraJAK · Traditional | Philips Healthcare (Suzhou) Co., Ltd. | 03/23/2026SE |
| K253574 | SOMATOM X.cite; SOMATOM X.ceedJAK · Traditional | Siemens Medical Solutions USA, Inc. | 03/20/2026SE |
More from Siemens Medical Solutions USA, Inc.
| 510(k) | Device | Decision |
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| K960948 | Scatter Correction Volume Software Model NSSC-020AKPS · Traditional | 12/23/1996SE |
| K954310 | BLA-800AKPW · Traditional | 10/18/1995SE |
| K954309 | AngiorexIZI · Traditional | 10/06/1995SE |
| K893750 | MRT-50A MobileLNH · Traditional | 08/09/1989SE |
| K891453 | Diagnostic Ultrasound Transducer: PVE-582VIYO · Traditional | 06/01/1989SE |
| K890969 | Transesophageal Transducer PEF-511SAIYO · Traditional | 05/16/1989SE |
| K884788 | Toshiba TCT-600XT Computed Tomography X-Ray SystemJAK · Traditional | 02/27/1989SE |
| K884555 | TCT-600HQ Compu Tomo(Ct)Xray/Head/Whole Body ExamJAK · Traditional | 02/27/1989SE |
| K883359 | Diagnostic Ultrasound System SSA-270AIYO · Traditional | 01/25/1989SE |
| K883756 | Toshiba MRT-50A Magnetic Resonance SystemLNH · Traditional | 11/14/1988SE |
Questions and answers
When was TCT-300S Computed Tomo. (CT) X-Ray System for Exam cleared by the FDA?
TCT-300S Computed Tomo. (CT) X-Ray System for Exam (K881305) received a 510(k) decision of Substantially Equivalent on October 19, 1988, 205 days after the submission was received.
What is the product code of K881305?
The FDA product code is JAK – System, X-Ray, Tomography, Computed, a Class II (moderate risk) device regulated under 21 CFR 892.1750.