510(k) K801168
- Device
- COLLIMAX X-RAY COLLIMATOR # R-182
- Applicant
- ITO X-RAY CORP.
- 510(k) number
- K801168
- Product code
- IZX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1980-07-08
- Date received
- 1980-05-15
- Regulation
- 892.1610
- Classification name
- Collimator, Manual, Radiographic
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 1418964
- 3029916061
- 3007137304
- 3003768277
- 9680895
- 1219183
- 3006551157
- 2243057
- 1450503
- 2424472
- 3023546785
- 8030233
- 3042175844
- 3021544569
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code IZX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K110856 | RALCO | Ralco S.R.L. | 2011-08-10 |
| K101036 | SHIMADZU COLLIMATOR R-20J | Shimadzu Corp. | 2010-08-26 |
| K042840 | SHIMADZU COLLIMATOR R-20J | Shimadzu Corp. | 2004-12-03 |
| K031771 | SHIMADZU COLLIMATOR R-30H | Shimadzu Corp. | 2003-08-21 |
| K981267 | FACTS MONOBLOCK | Dynarad Corp. | 1998-05-06 |
| K974240 | LIGHTLINE-M | Wuestec Medical, Inc. | 1997-12-22 |
| K972966 | AXT 150M MANUAL COLLIMATOR (AXT 150M) | Applied X-Ray Technologies, Inc. | 1997-08-21 |
| K932134 | RINN UNIVERSAL COLLIMATOR | Rinn Corp. | 1993-07-26 |
| K912180 | MODEL MGB-301 DIAPHRAGM FILM 24 X 30 CM | Instrumentarium Imaging, Inc. | 1991-10-21 |
| K900007 | R-100-ET MANUAL COLLIMATOR | Advantech | 1990-02-06 |
| K896486 | R-150-ET COLLIMATOR | Advantech | 1990-01-23 |
| K874687 | COLLI-MATETM MODEL NO. B800 | Summit Industries, Inc. | 1987-12-30 |
| K861941 | COLLIMATOR MODEL A280BLMD & MODEL A280BLMP | D&R X-Ray Products, Inc. | 1986-07-25 |
| K840678 | UXM MODEL 8188 | Universal X-Ray | 1984-03-16 |
| K780736 | CT 5221 DOSE REDUCING COLLIMATORS | Emi Medical, Inc. | 1978-06-02 |
Legacy Summary#
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
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