Device, Beam Limiting, X-Ray, Diagnostic
This device is a diagnostic x-ray beam limiting device, such as a collimator or cone, used to restrict the x-ray beam to the area of clinical interest, reducing patient radiation exposure during diagnostic imaging. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification. The product code is KPW, regulated under 21 CFR 892.1610 within the Radiology specialty. No special flags apply.
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Basic Information
- Product Code
- KPW
- Device Class
- FDA class 2
- Regulation Number
- 892.1610
- Medical Specialty
- Radiology
- Review Panel
- RA
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 16 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K093596 | LUMOS, MODEL R 72B | Jan 12, 2010 | Substantially Equivalent | Lumos, Inc. |
| K062788 | COLLIMATOR, MODEL M-38 | Dec 28, 2006 | Substantially Equivalent | Umi International |
| K030487 | R 72 | Aug 01, 2003 | Substantially Equivalent | Ralco S.R.L. |
| K954310 | BLA-800A | Oct 18, 1995 | Substantially Equivalent | Toshiba Medical Systems |
| K946320 | R 302 | May 11, 1995 | Substantially Equivalent | Ralco S.R.L. |
| K914184 | P2020-8-0 BEAM-LIMITING DEVICE | Nov 27, 1991 | Substantially Equivalent | Precise Optics |
| K904587 | DENSICOMP 250 | Jan 24, 1991 | Substantially Equivalent | L. Keroack Co. |
| K904044 | TF-63SA | Nov 29, 1990 | Substantially Equivalent | Toshiba America Medical Systems, In.C |
| K904489 | EUREKA EXTENSION CYLINDERS | Oct 15, 1990 | Substantially Equivalent | Eureka X-Ray Tube Corp. |
| K820306 | RALCO COLLIMATOR, AUTOMATIC RADIOGRAPHIC | Mar 05, 1982 | Substantially Equivalent | Tecnomed, Inc. |
| K820305 | RALCO COLLIMATORS, MANUAL RADIOGRAPHIC | Mar 04, 1982 | Substantially Equivalent | Tecnomed, Inc. |
| K820119 | PODIOSCOPE BY ARROW | Feb 18, 1982 | Substantially Equivalent | Arrow X-Ray Corp. |
| K811450 | ALUMINUM FILTRATION SYSTEM | Jul 02, 1981 | Substantially Equivalent | Wedge Filtration System |
| K791504 | AUTOMATIC POSITIVE BEAM COLLIMATOR | Sep 07, 1979 | Substantially Equivalent | Dial-X Instruments, Inc. |
| K781984 | COLLIMATOR, HEART CONTOUR | Dec 04, 1978 | Substantially Equivalent | Siemens Corp. |
| K770335 | COLLIMATOR, AUTOMATIC | Feb 28, 1977 | Substantially Equivalent | Litton Medical Systems |
FEI Numbers
This FDA classification entry is associated with 9 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 9 registration numbers. Click on an entry to view related FDA registrations.