510(k) K142647
- Device
- Mint Lesion
- Applicant
- MINT MEDICAL GMBH
- 510(k) number
- K142647
- Product code
- LLZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2015-04-13
- Date received
- 2014-09-17
- Regulation
- 892.2050
- Classification name
- System, Image Processing, Radiological
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Jochen Neuhaus
- Address
- Friedrich-Elbert-Str.2 Dossenheim DE 69221 69221
FDA Registration Numbers#
- 3003775006
- 3009717300
- 2020550
- 3013497030
- 3030982377
- 2936485
- 3015763655
- 3017585294
- 3026612481
- 3013695852
- 3016824824
- 3027347389
- 3004730352
- 3007362683
- 8043836
- 3010377510
- 3038177848
- 9680825
- 3017058304
- 3029877582
- 9615010
- 3003768277
- 3014343888
- 3038136528
- 3007194257
- 3009598843
- 3043532712
- 3017936680
- 3004198450
- 3013660213
- 1056553
- 9614981
- 3014665798
- 1032347
- 1054415
- 3038136320
- 3008496839
- 2126677
- 3035371452
- 3017140520
- 3008693672
- 3006542593
- 3030977776
- 3016851379
- 9616389
- 1644408
- 2937707
- 3021559833
- 1226003
- 3012916784
- 3011676026
- 3016579137
- 3021551875
- 1825014
- 3021637148
- 3003757027
- 3009532935
- 3009341091
- 3021233709
- 3024820186
- 3033525987
- 3014004349
- 3016954909
- 3045159436
- 3019544554
- 9615439
- 3004951433
- 3009756153
- 2954921
- 3010342382
- 1226188
- 3015218501
- 3012911444
- 3030979155
- 2031966
- 1721964
- 3005718816
- 3026391019
- 3014498512
Source Documents#
Other 510(k) Records For Product Code LLZ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K262120 | Avara Viewer | Avara Software | 2026-07-10 |
| K253899 | 3D-Anywhere | Provect.AI | 2026-07-09 |
| K261465 | INDIRA CLOUD VIEWER | INDIGO TECHNOLOGIES | 2026-07-06 |
| K260576 | MeVis AVM Contour | MeVis Medical Solutions AG | 2026-06-30 |
| K260231 | MiPACS V5 (1.0.0) | Apryse Software Corp | 2026-06-25 |
| K253421 | Perfusion Measurement Platform v1 | Quantified Imaging Limited | 2026-06-22 |
| K261352 | 2D Hip Planning Software | One Ortho | 2026-06-08 |
| K260116 | CustoMED Viewer | CustoMED , Ltd. | 2026-06-03 |
| K254265 | Helion Viewer Suite | Videomed Srl ( a Baxter Healthcare Corp company) | 2026-05-27 |
| K253831 | CMN Capillary Function with Virtual Expert for MRI, CT and CBCT | Cercare Medical A/S | 2026-05-18 |
| K254013 | SubtleHD-PET (1.x) | Subtle Medical, Inc. | 2026-05-14 |
| K260321 | HipGuide (V 1.0.0.0) | Orthopedic Driven Imaging, LLC | 2026-05-08 |
| K260716 | Neowise | Cefla S.C. | 2026-05-04 |
| K260009 | LungPoint Virtual Bronchoscopic Navigation (VBN) Software | Broncus Medical, Inc. | 2026-04-24 |
| K254237 | CCI PACS VIEWER (PACS-US-001) | CliniComp, Intl. | 2026-04-23 |
Legacy Summary#
summary
FDA Review#
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