Browse hierarchy: [Radiology (RA)](/submissions/RA) → [Subpart B — Diagnostic Devices](/submissions/RA/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 892.1610](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/892.1610) → KPW — Device, Beam Limiting, X-Ray, Diagnostic

# KPW · Device, Beam Limiting, X-Ray, Diagnostic

_Radiology · 21 CFR 892.1610 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPW

## Overview

- **Product Code:** KPW
- **Device Name:** Device, Beam Limiting, X-Ray, Diagnostic
- **Regulation:** [21 CFR 892.1610](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/892.1610)
- **Device Class:** 2
- **Review Panel:** [Radiology](/submissions/RA)

## 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](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPW/K093596.md) | LUMOS, MODEL R 72B | Lumos, Inc. | Jan 12, 2010 | SESE |
| [K062788](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPW/K062788.md) | COLLIMATOR, MODEL M-38 | Umi International | Dec 28, 2006 | SESE |
| [K030487](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPW/K030487.md) | R 72 | Ralco S.R.L. | Aug 1, 2003 | SESE |
| [K954310](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPW/K954310.md) | BLA-800A | Toshiba Medical Systems | Oct 18, 1995 | SESE |
| [K946320](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPW/K946320.md) | R 302 | Ralco S.R.L. | May 11, 1995 | SESE |
| [K914184](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPW/K914184.md) | P2020-8-0 BEAM-LIMITING DEVICE | Precise Optics | Nov 27, 1991 | SESE |
| [K904587](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPW/K904587.md) | DENSICOMP 250 | L. Keroack Co. | Jan 24, 1991 | SESE |
| [K904044](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPW/K904044.md) | TF-63SA | Toshiba America Medical Systems, In.C | Nov 29, 1990 | SESE |
| [K904489](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPW/K904489.md) | EUREKA EXTENSION CYLINDERS | Eureka X-Ray Tube Corp. | Oct 15, 1990 | SESE |
| [K820306](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPW/K820306.md) | RALCO COLLIMATOR, AUTOMATIC RADIOGRAPHIC | Tecnomed, Inc. | Mar 5, 1982 | SESE |
| [K820305](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPW/K820305.md) | RALCO COLLIMATORS, MANUAL RADIOGRAPHIC | Tecnomed, Inc. | Mar 4, 1982 | SESE |
| [K820119](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPW/K820119.md) | PODIOSCOPE BY ARROW | Arrow X-Ray Corp. | Feb 18, 1982 | SESE |
| [K811450](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPW/K811450.md) | ALUMINUM FILTRATION SYSTEM | Wedge Filtration System | Jul 2, 1981 | SESE |
| [K791504](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPW/K791504.md) | AUTOMATIC POSITIVE BEAM COLLIMATOR | Dial-X Instruments, Inc. | Sep 7, 1979 | SESE |
| [K781984](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPW/K781984.md) | COLLIMATOR, HEART CONTOUR | Siemens Corp. | Dec 4, 1978 | SESE |
| [K770335](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPW/K770335.md) | 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

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**Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPW](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPW)

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