BLA-800A
FDA 510(k) K954310 · Toshiba Medical Systems
510(k) numberK954310
Submission
- Device name
- BLA-800A
- Applicant
- Toshiba Medical Systems
Tustin, CA, US - Received
- September 15, 1995
- Decision date
- October 18, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K030487 | R 72KPW · Traditional | Ralco S.R.L. | 08/01/2003SE |
| K946320 | R 302KPW · Traditional | Ralco S.R.L. | 05/11/1995SE |
| K914184 | P2020-8-0 Beam-Limiting DeviceKPW · Traditional | Precise Optics | 11/27/1991SE |
| K904587 | Densicomp 250KPW · Traditional | L. Keroack Co. | 01/24/1991SE |
| K904044 | TF-63SAKPW · Traditional | Toshiba America Medical Systems, In.C | 11/29/1990SE |
| K904489 | Eureka Extension CylindersKPW · Traditional | Eureka X-Ray Tube Corp. | 10/15/1990SE |
| K820306 | Ralco Collimator, Automatic RadiographicKPW · Traditional | Tecnomed, Inc. | 03/05/1982SE |
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More from Tecnomed, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K960948 | Scatter Correction Volume Software Model NSSC-020AKPS · Traditional | 12/23/1996SE |
| 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 |
| K881305 | TCT-300S Computed Tomo. (CT) X-Ray System for ExamJAK · Traditional | 10/19/1988SE |
Questions and answers
When was BLA-800A cleared by the FDA?
BLA-800A (K954310) received a 510(k) decision of Substantially Equivalent on October 18, 1995, 33 days after the submission was received.
What is the product code of K954310?
The FDA product code is KPW – Device, Beam Limiting, X-Ray, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 892.1610.