FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MR GUIDED PROCEDURES (MRGP) BASIC PACKAGE
K Number: K983342
·
Decision Dec 21, 1998
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
87
Applicant Total
181
Review Days
89
Basic Information
- Device Name
- MR GUIDED PROCEDURES (MRGP) BASIC PACKAGE
- K Number
- K983342
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
- Date Received
- September 23, 1998
- Decision Date
- December 21, 1998
- Product Code
- LHN
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LHN | System, Radiation Therapy, Charged-Particle, Medical | FDA class 2 | Radiology |
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|---|---|---|---|
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| K083498 | PHILIPS MODEL MX 16 SLICE CT SYSTEM | Dec 17, 2008 | Substantially Equivalent |
| K081426 | NEXSTAR LIFTOFF PET APPLICATION SOFTWARE SUITE | Jun 4, 2008 | Substantially Equivalent |
| K081135 | GEMINI CONDOR | Apr 29, 2008 | Substantially Equivalent |
| K080927 | BRIGHTVIEW VCT IMAGING SYSTEM | Apr 11, 2008 | Substantially Equivalent |
| K060937 | BRILLIANCE VOLUME | Jun 5, 2006 | Substantially Equivalent |