Cronex Radiation Therapy Cassette
FDA 510(k) K953724 · E.I. Dupont DE Nemours & Co., Inc.
510(k) numberK953724
Submission
- Device name
- Cronex Radiation Therapy Cassette
- Applicant
- E.I. Dupont DE Nemours & Co., Inc.
Newark, DE, US - Received
- August 10, 1995
- Decision date
- September 6, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K983918 | Radiolucent Cassette Limb Positioner (R-Clip)IXA · Traditional | Mastek, Inc. | 03/12/1999SE |
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| 510(k) | Device | Decision |
|---|---|---|
| K951851 | Alliance Cytomegalovirus Immediate Early Antigen Direct Immunofluorescence AssayLJO · Traditional | 07/24/1996SE |
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| K951441 | Dupont Aca Digoxin (DGN a) MethodKXT · Traditional | 06/01/1995SE |
| K950137 | Urine Barbiturates Screen Flex(Tm) Reagent CartridgeDIS · Traditional | 04/13/1995SE |
| K950181 | Urine Cannabinoids Screen Flex(Tm) Reagent CartridgeLDJ · Traditional | 04/05/1995SE |
| K950136 | Urine Opiates Screen Flex(Tm) Reagent CartridgeDJG · Traditional | 04/05/1995SE |
| K950135 | Urine Amphetamines Screen Flex(Tm) Reagent CartridgeDKZ · Traditional | 03/30/1995SE |
| K950427 | Urine Benzodiazepines Screen Flex Teagent CartridgeJXM · Traditional | 03/21/1995SE |
| K950182 | Urine Methadone Screen Flex(Tm) Reagent CartridgeDIW · Traditional | 03/21/1995SE |
| K950134 | Urine Cocaine Metabolite Screen Flex(Tm) Reagent CatridgeDLN · Traditional | 03/21/1995SE |
Questions and answers
When was Cronex Radiation Therapy Cassette cleared by the FDA?
Cronex Radiation Therapy Cassette (K953724) received a 510(k) decision of Substantially Equivalent on September 6, 1995, 27 days after the submission was received.
What is the product code of K953724?
The FDA product code is IXA – Cassette, Radiographic Film, a Class II (moderate risk) device regulated under 21 CFR 892.1850.