Dial X Collimator Model A&B
FDA 510(k) K771689 · Bennett X-Ray Corp.
510(k) numberK771689
Submission
- Device name
- Dial X Collimator Model A&B
- Applicant
- Bennett X-Ray Corp.
Mchenry, IL, US - Received
- September 6, 1977
- Decision date
- September 14, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code IZX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K110856 | RalcoIZX · Traditional | Ralco S.R.L. | 08/10/2011SE |
| K101036 | Shimadzu Collimator R-20JIZX · Abbreviated | Shimadzu Corp. | 08/26/2010SE |
| K042840 | Shimadzu Collimator R-20JIZX · Abbreviated | Shimadzu Corp. | 12/03/2004SE |
| K031771 | Shimadzu Collimator R-30HIZX · Abbreviated | Shimadzu Corp. | 08/21/2003SE |
| K981267 | Facts MonoblockIZX · Traditional | Dynarad Corp. | 05/06/1998SE |
| K974240 | Lightline-MIZX · Traditional | Wuestec Medical, Inc. | 12/22/1997SE |
| K972966 | Axt 150M Manual Collimator (Axt 150M)IZX · Traditional | Applied X-Ray Technologies, Inc. | 08/21/1997SE |
| K932134 | Rinn Universal CollimatorIZX · Traditional | Rinn Corp. | 07/26/1993SE |
| K912180 | Model MGB-301 Diaphragm Film 24 X 30 CMIZX · Traditional | Instrumentarium Imaging, Inc. | 10/21/1991SE |
| K900007 | R-100-ET Manual CollimatorIZX · Traditional | Advantech | 02/06/1990SE |
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|---|---|---|
| K964576 | Profile Mammography System (M-Pro)IZH · Traditional | 01/10/1997SE |
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| K944978 | Bennett X-Ray Digital Spot Imaging System Model M-DsiIZH · Traditional | 05/03/1995SE |
| K945962 | Bennett X-Ray Profile Positioning Paddle for MammographyIZH · Traditional | 04/03/1995SE |
| K945749 | Bennett X-Ray Tomography SystemIZF · Traditional | 02/15/1995SE |
| K945731 | HFQ High Frequency Radiographic and Fluroscopic GeneratorsIZO · Traditional | 02/15/1995SE |
| K940701 | Bennett Mammography Positioning Chair Model No. M-PchIZH · Traditional | 04/28/1994SE |
| K935649 | Whis-Rad Tubstand Structure/Mobile Patient TrolleyKPR · Traditional | 02/09/1994SE |
| K935068 | Radiographic Generator Hfq-WhisIZO · Traditional | 12/13/1993SE |
| K925725 | Contour Mammography System, Model Number M-CtrIZH · Traditional | 02/26/1993SE |
Questions and answers
When was Dial X Collimator Model A&B cleared by the FDA?
Dial X Collimator Model A&B (K771689) received a 510(k) decision of Substantially Equivalent on September 14, 1977, 8 days after the submission was received.
What is the product code of K771689?
The FDA product code is IZX – Collimator, Manual, Radiographic, a Class II (moderate risk) device regulated under 21 CFR 892.1610.