510(k) K092041
- Device
- STELLAR FIDUCIAL MARKER, MODEL GFMIA
- Applicant
- STELLAR MEDICAL LLC.
- 510(k) number
- K092041
- Product code
- IYE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2009-10-02
- Date received
- 2009-07-07
- Regulation
- 892.5050
- Classification name
- Accelerator, Linear, Medical
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- BENJAMIN ROEDELL
- Address
- 12738 Buckhorn Dr. Hudson FL US 34669 34669
FDA Registration Numbers
- 9613183
- 1450662
- 3016686005
- 3015620182
- 3012205931
- 1932738
- 3003793371
- 3007615597
- 3022719374
- 3015621321
- 3019552217
- 1651102
- 1526854
- 3001722928
- 2183744
- 3009894282
- 3009039068
- 3009077524
- 3013012623
- 3016591365
- 3027080417
- 3002808157
- 3015548663
- 3033484057
- 3025765259
- 3010875109
- 2184007
- 3015232217
- 1000162206
- 3004753785
- 3007350713
- 2182762
- 1123169
- 9616684
- 3012631246
- 3007546534
- 3005099803
- 3006621300
- 3002807314
- 9614952
- 1530561
- 3003803149
- 3010625741
- 2155
- 3004580128
- 3011716550
- 3006073271
- 8043933
- 3008317830
- 3013410552
- 3009649442
- 3009773332
- 9710332
- 3003094912
- 3007165183
- 3015496236
- 3003768277
- 3014428919
- 9681124
- 3009754495
- 3009394603
- 2431392
- 3026961165
- 3004637983
- 3006981798
- 3022973841
- 3014113695
- 3004962788
- 3003477135
- 3014404697
- 3031194398
- 3012039133
- 1720929
- 1055485
- 3018004899
- 9614584
- 3006405073
- 9617016
- 1647149
- 1000523114
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00853162006430 | Stellar Medical | STELLAR MEDICAL, LLC | 2020-05-28 |
| 00853162006447 | Stellar Medical | STELLAR MEDICAL, LLC | 2020-05-28 |
| 00853162006577 | Stellar Medical | STELLAR MEDICAL, LLC | 2020-05-28 |
| 00853162006607 | Stellar Medical | STELLAR MEDICAL, LLC | 2020-05-28 |
| 00853162006584 | Stellar Medical | STELLAR MEDICAL, LLC | 2019-05-29 |
| 00853162006485 | Stellar Medical | STELLAR MEDICAL, LLC | 2019-05-15 |
| 00853162006560 | Stellar Medical | STELLAR MEDICAL, LLC | 2019-05-15 |
| 00853162006553 | Stellar Medical | STELLAR MEDICAL, LLC | 2019-05-15 |
| 00853162006546 | Stellar Medical | STELLAR MEDICAL, LLC | 2019-05-15 |
| 00853162006539 | Stellar Medical | STELLAR MEDICAL, LLC | 2019-05-15 |
| 00853162006522 | Stellar Medical | STELLAR MEDICAL, LLC | 2019-05-15 |
| 00853162006515 | Stellar Medical | STELLAR MEDICAL, LLC | 2019-05-15 |
| 00853162006508 | Stellar Medical | STELLAR MEDICAL, LLC | 2019-05-15 |
| 00853162006492 | Stellar Medical | STELLAR MEDICAL, LLC | 2019-05-15 |
| 00853162006478 | Stellar Medical | STELLAR MEDICAL, LLC | 2019-05-15 |
| 00853162006461 | Stellar Medical | STELLAR MEDICAL, LLC | 2019-05-15 |
| 00853162006454 | Stellar Medical | STELLAR MEDICAL, LLC | 2019-05-15 |
| 00853162006423 | Stellar Medical | STELLAR MEDICAL, LLC | 2016-09-30 |
| 00853162006416 | Stellar Medical | STELLAR MEDICAL, LLC | 2016-09-19 |
| 00853162006317 | Stellar Medical | STELLAR MEDICAL, LLC | 2016-08-17 |
| 00853162006027 | Stellar Medical | STELLAR MEDICAL, LLC | 2016-08-17 |
| 00853162006010 | Stellar Medical | STELLAR MEDICAL, LLC | 2016-08-17 |
| 00853162006003 | Stellar Medical | STELLAR MEDICAL, LLC | 2016-08-17 |
| 00853162006249 | Stellar Medical | STELLAR MEDICAL, LLC | 2016-08-17 |
| 00853162006256 | Stellar Medical | STELLAR MEDICAL, LLC | 2016-08-17 |
| 00853162006263 | Stellar Medical | STELLAR MEDICAL, LLC | 2016-08-17 |
| 00853162006270 | Stellar Medical | STELLAR MEDICAL, LLC | 2016-08-17 |
| 00853162006287 | Stellar Medical | STELLAR MEDICAL, LLC | 2016-08-17 |
| 00853162006294 | Stellar Medical | STELLAR MEDICAL, LLC | 2016-08-17 |
| 00853162006300 | Stellar Medical | STELLAR MEDICAL, LLC | 2016-08-17 |
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Legacy Summary
summary
FDA Review
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