KPW · Device, Beam Limiting, X-Ray, Diagnostic
Radiology · 21 CFR 892.1610 · Class 2
Overview
| Product Code | KPW |
|---|---|
| Device Name | Device, Beam Limiting, X-Ray, Diagnostic |
| Regulation | 21 CFR 892.1610 |
| Device Class | Class 2 |
| Review Panel | Radiology |
Identification
A diagnostic x-ray beam-limiting device is a device such as a collimator, a cone, or an aperture intended to restrict the dimensions of a diagnostic x-ray field by limiting the size of the primary x-ray beam.
Classification Rationale
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
Recent Cleared Devices (16 of 16)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K093596 | LUMOS, MODEL R 72B | Lumos, Inc. | Jan 12, 2010 | SESE |
| K062788 | COLLIMATOR, MODEL M-38 | Umi International | Dec 28, 2006 | SESE |
| K030487 | R 72 | Ralco S.R.L. | Aug 1, 2003 | SESE |
| K954310 | BLA-800A | Toshiba Medical Systems | Oct 18, 1995 | SESE |
| K946320 | R 302 | Ralco S.R.L. | May 11, 1995 | SESE |
| K914184 | P2020-8-0 BEAM-LIMITING DEVICE | Precise Optics | Nov 27, 1991 | SESE |
| K904587 | DENSICOMP 250 | L. Keroack Co. | Jan 24, 1991 | SESE |
| K904044 | TF-63SA | Toshiba America Medical Systems, In.C | Nov 29, 1990 | SESE |
| K904489 | EUREKA EXTENSION CYLINDERS | Eureka X-Ray Tube Corp. | Oct 15, 1990 | SESE |
| K820306 | RALCO COLLIMATOR, AUTOMATIC RADIOGRAPHIC | Tecnomed, Inc. | Mar 5, 1982 | SESE |
| K820305 | RALCO COLLIMATORS, MANUAL RADIOGRAPHIC | Tecnomed, Inc. | Mar 4, 1982 | SESE |
| K820119 | PODIOSCOPE BY ARROW | Arrow X-Ray Corp. | Feb 18, 1982 | SESE |
| K811450 | ALUMINUM FILTRATION SYSTEM | Wedge Filtration System | Jul 2, 1981 | SESE |
| K791504 | AUTOMATIC POSITIVE BEAM COLLIMATOR | Dial-X Instruments, Inc. | Sep 7, 1979 | SESE |
| K781984 | COLLIMATOR, HEART CONTOUR | Siemens Corp. | Dec 4, 1978 | SESE |
| K770335 | COLLIMATOR, AUTOMATIC | Litton Medical Systems | Feb 28, 1977 | SESE |
Top Applicants
- Tecnomed, Inc. — 2 clearances
- Ralco S.R.L. — 2 clearances
- Wedge Filtration System — 1 clearance
- Umi International — 1 clearance
- Toshiba Medical Systems — 1 clearance
