510(k) K231668
- Device
- Spine CAMP? (1.1)
- Applicant
- Medical Metrics, Inc.
- 510(k) number
- K231668
- Product code
- QIH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-07-07
- Date received
- 2023-06-07
- Regulation
- 892.2050
- Classification name
- Automated Radiological Image Processing Software
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Kirk Johnson
- Address
- 2121 Sage Rd. Suite 300 Houston TX US 77056 77056
FDA Registration Numbers#
- 3032109181
- 8043933
- 3027977501
- 3014809646
- 3032367
- 3014132130
- 3012981490
- 3027347389
- 2518586
- 3000126629
- 8030233
- 3024972425
- 3012987001
- 3006209933
- 3008693672
- 3032807464
- 3033527273
- 9617277
- 3014310698
- 1226773
- 3016585383
- 3023245
- 3033527241
- 8043836
- 3017487805
- 9615849
- 3021970996
- 1826555
- 3031915908
- 3020928588
- 2532090
- 3028006458
- 3005225421
- 3017840913
- 3020331900
- 3002183074
- 3013306229
- 3015218501
- 3010952312
- 3031569584
- 3013561205
- 3033557977
- 3025602618
- 3018064242
- 3029900829
- 3022719380
- 3009758186
- 3022973841
- 3000976525
- 3024812789
- 3017233423
- 9710645
- 3017297314
- 3029923647
- 9614698
- 3019216
- 3008496839
- 3016446349
- 8022257
- 3044737887
- 3035386366
- 9710122
- 9680825
- 3005369776
- 3019541896
- 9612283
- 3035950510
- 3013410552
- 3001675293
- 3017173128
- 3018733944
- 2032350
- 3020703662
- 3008284470
- 3007630531
- 3023217364
- 9616251
- 3021561977
- 3008007310
Source Documents#
Other 510(k) Records For Product Code QIH#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260879 | 4DM | INVIA, LLC | 2026-09-10 |
| K261795 | Quicktome Software Suite | Omniscient Neurotechnology Pty, Ltd. | 2026-09-10 |
| K251417 | ReVISION 2 | Argus Cognitive, Inc. | 2026-09-09 |
| K260525 | NextMR Spine | MRI2CT, Inc. | 2026-09-04 |
| K260811 | Heartvue.Proton | Heartvue.ai, Inc. | 2026-08-26 |
| K261595 | Ceevra Reveal 4 | Ceevra, Inc. | 2026-08-25 |
| K260584 | BoneMRI | Mriguidance B.V. | 2026-08-21 |
| K262127 | DS Core CBCT Anatomy | Dentsply Sirona | 2026-08-21 |
| K261641 | Lower Limb AI (LLAI) | AI Planning Logic, Inc. | 2026-08-18 |
| K253794 | Prostate Core | Lucida Medical, Ltd. | 2026-08-10 |
| K252571 | mdprostate | Mediaire GmbH | 2026-08-07 |
| K253902 | RealGUIDE | 3DIEMME SRL | 2026-08-04 |
| K253835 | Affinity | Hermes Medical Solutions AB | 2026-07-31 |
| K260980 | cmAngio® V2.0 | Curemetrix, Inc. | 2026-07-30 |
| K261210 | Cleerly Plaque | Cleerly, Inc. | 2026-07-29 |