PHILIPS GALLILEO AUTOMATIC COLLIMATOR (OR BEAM LIMITING DEVICE)
FDA 510(k) clearance K951372 · decided 1995-05-04
Clearance details
- K-number
- K951372
- Device name
- PHILIPS GALLILEO AUTOMATIC COLLIMATOR (OR BEAM LIMITING DEVICE)
- Applicant
- Philips Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-03-27
- Decision date
- 1995-05-04
- Days to decision
- 38 days
- Clearance type
- Traditional
- Product code
- IZW
- Device class
- 2
- Regulation number
- 892.1610
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Shelton, CT, US
- Third-party review
- No
- Expedited review
- No
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Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| SHIMADZU COLLIMATOR R-300 (K101039) | Shimadzu Corp. | 2010-09-20 |
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| SHIMADZU COLLIMATOR R-30H (K090578) | Shimadzu Corp. | 2009-11-06 |
| RALCO, MODEL R225 ACS (K091517) | Ralco S.R.L. | 2009-07-14 |
| MODEL R605DASM AUTOMATIC X-RAY COLLIMATOR (K083029) | Ralco S.R.L. | 2008-12-05 |
| MODEL R302DACS/A AUTOMATIC X-RAY COLLIMATOR (K072780) | Ralco S.R.L. | 2007-11-26 |
| COLLIMARE COLLIMATOR FAMILY (K073124) | Collimare, LLC | 2007-11-16 |
| R605 FACS COLLIMETER (K050092) | Omega Medical Imaging, Inc. | 2005-01-31 |
| DUNLEE FORMAT COLLIMATOR FAMILY (K031597) | Philips Medical Systems North America Co. | 2003-07-21 |
| PHILIPS NICOL COLLIMATOR FAMILY (K990423) | Philips Medical Systems, Inc. | 1999-03-15 |
| XRE COLLIMATOR WITH SPECTRAL FILTER (K984414) | Trex Medical Corp. | 1998-12-30 |
| XRE COLLIMATOR (K960998) | Xre Corp. | 1996-04-03 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Philips Gallileo Automatic Collimator, Part Numbers: 9896 010 00612, 9896 010 00614, 9896 recall (Z-1886-2008) | Philips Medical Systems North America Co. Phillips | 2008-09-16 |