510(k) K924443
- Device
- RS-3 UNIVERSAL RADIOGRAPHIC WORKING PLACE
- Applicant
- CONTROL-X, INC.
- 510(k) number
- K924443
- Product code
- IZF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1993-02-05
- Date received
- 1992-09-01
- Regulation
- 892.1740
- Classification name
- System, X-ray, Tomographic
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- ZSIGMOND KOVACS
- Address
- 2289 Westbrooke Dr. Columbus OH US 43228 43228
FDA Registration Numbers#
- 9613152
- 3013679558
- 3022810909
- 3009963139
- 3008284470
- 3008496839
- 3001556265
- 3011825597
- 2243057
- 3031503890
- 3014018042
- 3027605321
- 3001722928
- 2126677
- 8020997
- 3023003446
- 3003775006
- 9613445
- 9616047
Source Documents#
510(k) summary PDF not indicated by FDA
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| K121499 | FUJIFILM TOMOSYNTHESIS OPTION FOR FDR ACSELERATE STATIONARY X-RAY SYSTEM | Fujifilm Medical System U.S.A., Inc. | 2012-11-20 |
| K013620 | MEDSTONE, UROPRO 2000, TOMOGRAPHIC OPTION | Medstone Intl., Inc. | 2002-01-22 |
| K011290 | PROGNOST ES, MODEL 0302 0000 | Xmar Corp. | 2001-05-30 |
| K973864 | COMBI ELEVATOR-2 & COMBI ELEVATOR-2 TOMO | Pausch Corp. | 1998-06-17 |
| K973834 | CS2000 & CS2000 TOMO | Pausch Corp. | 1998-04-30 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases