Radiographic - Leg Section
FDA 510(k) K864846 · American Sterilizer Co.
510(k) numberK864846
Submission
- Device name
- Radiographic - Leg Section
- Applicant
- American Sterilizer Co.
Erie, PA, US - Received
- December 10, 1986
- Decision date
- December 24, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KQS – Table, Cystometric, Non-Electric And Accessories
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 876.4890
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code KQS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K955019 | Urotract IKQS · Traditional | Dornier Medtech America, Inc. | 12/06/1995SE |
| K872022 | UroviewKQS · Traditional | Oec-Diasonics, Inc. | 07/16/1987SE |
| K860040 | Hydrajust III Urological TableKQS · Traditional | Mallinckrodt Group, Inc. | 02/10/1986SE |
| K852127 | Amsco Uro-Endo Mobile TableKQS · Traditional | American Sterilizer Co. | 08/08/1985SE |
| K801723 | Ur 150-UR 150TKQS · Traditional | Siemens Corp. | 08/13/1980SE |
| K791699 | Hydradjust II Urological TableKQS · Traditional | Sybron Corp. | 10/22/1979SE |
| K760522 | Table, UrosurgicalKQS · Traditional | Mallinckrodt Group, Inc. | 12/16/1976SE |
More from Mallinckrodt Group, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K943288 | Amsco SQ240 Surgical LightFSY · Traditional | 10/17/1994SE |
| K931872 | The Eagle 3017 100% Ethylene Oxide SterilizerFLF · Traditional | 02/07/1994SE |
| K922485 | Chemdi-Vhp Chemical IndicatorJOJ · Traditional | 09/29/1993SE |
| K930493 | Quantum 3080 Surgical TableFQO · Traditional | 06/22/1993SE |
| K905816 | Orthovision TableJEB · Traditional | 03/06/1991SE |
| K896674 | Amsco Quantum LightFSY · Traditional | 01/03/1990SE |
| K895164 | Eagle DSECG · Traditional | 11/17/1989SE |
| K882660 | General Surgical Table and AccessoriesFQO · Traditional | 07/25/1988SE |
| K880198 | Gemini Surgical LightFSS · Traditional | 02/10/1988SE |
| K844479 | ChemsporFRC · Traditional | 11/25/1985SN |
Questions and answers
When was Radiographic - Leg Section cleared by the FDA?
Radiographic - Leg Section (K864846) received a 510(k) decision of Substantially Equivalent on December 24, 1986, 14 days after the submission was received.
What is the product code of K864846?
The FDA product code is KQS – Table, Cystometric, Non-Electric And Accessories, a Class I (low risk) device regulated under 21 CFR 876.4890.