510(k) K011604
- Device
- PROSTATE SPECTROSCOPY AND IMAGING EXAM (PROSE) SOFTWARE OPTION FOR MRI
- Applicant
- GE MEDICAL SYSTEMS, INC.
- 510(k) number
- K011604
- Product code
- LNI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2001-08-22
- Date received
- 2001-05-24
- Regulation
- 892.1000
- Classification name
- System, Nuclear Magnetic Resonance Spectroscopic
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- LARRY A KROGER
- Address
- P.O. Box 414 Milwaukee WI US 53201 53201
FDA Registration Numbers#
- 3010326005
- 3027339477
- 3003768277
- 3029521953
- 3009077524
- 3031503890
- 3016851825
- 3012085143
- 3015276088
- 3004754211
- 3000126629
- 3009196578
- 3013875850
- 3012127758
- 3005049692
- 3007350713
- 3042177665
- 3011416394
- 3032109181
- 3008632256
- 3012939903
- 3008447096
- 3008355361
- 9613936
- 3018423337
- 3036666444
- 3010398867
- 9616047
- 3009154005
- 3032109225
- 3026047529
- 3012169560
- 3021059265
- 3005326970
- 3005877899
- 2183553
- 3035371452
- 3007562060
- 3014343100
- 3023003446
- 3008284470
- 3033527281
- 3010949642
- 3015329423
- 3005810333
- 3002808157
- 3017375271
- 3004531751
- 1529041
Source Documents#
Other 510(k) Records For Product Code LNI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K093044 | OASIS MRI SYSTEM | Hitachi Medical Systems America, Inc. | 2010-03-16 |
| K071506 | ECHELON SPECTROSCOPY PACKAGE | Hitachi Medical Systems America, Inc. | 2007-06-28 |
| K010129 | EXCELART WITH PIANISSIMO, MODEL MRT-1500/P3 | Toshiba America Medical Systems, In.C | 2001-04-05 |
| K003575 | MODIFICATION TO 3.0T SIGNA VH/I MAGNETIC RESONANCE SYSTEM | GE Medical Systems | 2001-01-17 |
| K991568 | MR SPECTROSCOPY PACKAGE | Philips Medical Systems (Cleveland), Inc. | 1999-07-19 |
| K984167 | SAGE 7 | GE Medical Systems | 1999-01-12 |
| K962627 | CLINICAL PHOSPHORUS SPECTROSCOPY OPTION/MAGNETOM VISION SYSTEM | Siemens Medical Solutions USA, Inc. | 1997-04-03 |
| K970005 | GYREX 2T-PRESTIGE | Elscint, Inc. | 1997-03-28 |
| K930265 | HYDROGEN SPECTROSCOPY OPTION-PROBE #M1040HS/HT | GE Medical Systems | 1995-04-25 |
Legacy Summary#
summary
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