510(k) K062788
- Device
- COLLIMATOR, MODEL M-38
- Applicant
- UMI INTERNATIONAL
- 510(k) number
- K062788
- Product code
- KPW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2006-12-28
- Date received
- 2006-09-18
- Regulation
- 892.1610
- Classification name
- Device, Beam Limiting, X-ray, Diagnostic
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- KWANG C JUNG
- Address
- 129 Kensington Ave. Norwood NJ US 07648 07648
FDA Registration Numbers#
- 3000126629
- 3013875850
- 3003768251
- 9680895
- 3014150341
- 3003202425
- 3002466018
- 8021091
- 3021544569
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KPW #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K093596 | LUMOS, MODEL R 72B | Lumos, Inc. | 2010-01-12 |
| K030487 | R 72 | Ralco S.R.L. | 2003-08-01 |
| K954310 | BLA-800A | Toshiba Medical Systems | 1995-10-18 |
| K946320 | R 302 | Ralco S.R.L. | 1995-05-11 |
| K914184 | P2020-8-0 BEAM-LIMITING DEVICE | Precise Optics | 1991-11-27 |
| K904587 | DENSICOMP 250 | L. Keroack Co. | 1991-01-24 |
| K904044 | TF-63SA | Toshiba America Medical Systems, In.C | 1990-11-29 |
| K904489 | EUREKA EXTENSION CYLINDERS | Eureka X-Ray Tube Corp. | 1990-10-15 |
| K820306 | RALCO COLLIMATOR, AUTOMATIC RADIOGRAPHIC | Tecnomed, Inc. | 1982-03-05 |
| K820305 | RALCO COLLIMATORS, MANUAL RADIOGRAPHIC | Tecnomed, Inc. | 1982-03-04 |
| K820119 | PODIOSCOPE BY ARROW | Arrow X-Ray Corp. | 1982-02-18 |
| K811450 | ALUMINUM FILTRATION SYSTEM | Wedge Filtration System | 1981-07-02 |
| K791504 | AUTOMATIC POSITIVE BEAM COLLIMATOR | Dial-X Instruments, Inc. | 1979-09-07 |
| K781984 | COLLIMATOR, HEART CONTOUR | Siemens Corp. | 1978-12-04 |
| K770335 | COLLIMATOR, AUTOMATIC | Litton Medical Systems | 1977-02-28 |
Legacy Summary#
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FDA Review#
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