Company · US
Deerfield Imaging, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2021 to 2024. Name variants (Inc, Corp, punctuation) are merged.
2510(k) clearances (0 in 12 months)
21recalls (0 in 12 months)
6recalls that name a 510(k)
Product codes
Latest 510(k) clearances
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 17, 2022 | Deerfield Imaging, Inc. Trumpf Mount Clamp Assembly (table adapter component), part #118704-000, a component of the IMRIS HFD100 head fixation device, models #119629-000 and #119630-000, which are used with ORT400 operating Terminated |
HBL | K103493 |
| Aug 25, 2021 | Deerfield Imaging, Inc. Operating room table - Product Usage: intended for use during diagnostic examinations, radiologic procedures or surgical procedures to support and position a patient. Terminated |
KXJ | None listed |
| Aug 25, 2021 | Deerfield Imaging, Inc. Operating room table - Product Usage: intended for use during diagnostic examinations, radiologic procedures or surgical procedures to support and position a patient. Terminated |
KXJ | None listed |
| Aug 25, 2021 | Deerfield Imaging, Inc. Operating room table - Product Usage: intended for use during diagnostic examinations, radiologic procedures or surgical procedures to support and position a patient. Terminated |
KXJ | None listed |
| Nov 26, 2019 | Deerfield Imaging, Inc. iMRX MRI and Angiography System, part number 10094137 and 10094141, a surgical/interventional suite with integrated MRI and X-ray angiography.
The IMRIS iMRX system is the integration of a Siemens A Terminated |
LNH | K101813 |
| Jun 26, 2019 | Deerfield Imaging, Inc. IMRIS MR/X-ray head fixation device, Model HFD200 Terminated |
HBL | K113748 |
| Nov 6, 2018 | Deerfield Imaging, Inc. IMRIS ORT 300, Removable Operating Room Table, Part Numbers: (a) 114093-000, (b) 114093-006 - Product Usage: The ORT200 and ORT300 are intended for use during diagnostic examinations, radiologic proc Terminated |
FQO | None listed |
| Nov 6, 2018 | Deerfield Imaging, Inc. IMRIS ORT 200, Removable Operating Room Table, Part Numbers: (a) 113821-000, (b) 113821-600, (c) 114148-000, (d) 114148-600 - Product Usage: The ORT200 and ORT300 are intended for use during diagnost Terminated |
FQO | None listed |
| Nov 6, 2018 | Deerfield Imaging, Inc. IMRIS ORT 100 table, Part Numbers: (a) 110470-000, (b) 110470-600 - Product Usage: The ORT200 and ORT300 are intended for use during diagnostic examinations, radiologic procedures, or surgical proced Terminated |
FQO | None listed |
| Nov 6, 2018 | Deerfield Imaging, Inc. IMRIS T2X table, Part Numbers: (a)108000-000, (b)108000-600, (c)109682-000, (d) 109682-600, (e) 110470-600 - Product Usage: The ORT200 and ORT300 are intended for use during diagnostic examinations, Terminated |
FQO | None listed |
| Apr 4, 2018 | Deerfield Imaging, Inc. IMRIS IMRI 1.5T AND 3T S System
Product Usage:
The IMRIS intraoperative MRI systems are traditional MRI systems that have been suspended on an overhead rail system. and is designated to operative ins Terminated |
LNH | K133692 |
| Feb 23, 2018 | Deerfield Imaging, Inc. IMRIS ORT300, Removable Operating Room Table, Part Numbers:
(a) 114093-000
(b) 114093-600 Terminated |
FQO | None listed |
| Feb 23, 2018 | Deerfield Imaging, Inc. IMRIS T2X Table, Part Numbers:
(a) 108000-000
(b) 108000-600
(c) 109682-000
(d) 109682-600 Terminated |
FQO | None listed |
| Feb 23, 2018 | Deerfield Imaging, Inc. IMRIS ORT200, Removable Operating Room Table, Part Numbers:
(a) 113821-000
(b) 113821-600
(c) 114148-000
(d) 114148-600 Terminated |
FQO | None listed |
| Feb 23, 2018 | Deerfield Imaging, Inc. IMRIS ORT100 Table, Part Numbers:
(a) 110470-000
(b) 110470-600 Terminated |
FQO | None listed |
| Feb 23, 2018 | Deerfield Imaging, Inc. IMRIS ORT300 Removable Operating Room Table, 50-60 Hz Version is intended for use during diagnostic examinations or surgical procedures to support and position a patient. Terminated |
FQO | None listed |
| Feb 23, 2018 | Deerfield Imaging, Inc. IMRIS ORT200 Removable Operating Room Table, 50-60 Hz Version is intended for use during diagnostic examinations or surgical procedures to support and position a patient. Terminated |
FQO | None listed |
| Feb 20, 2018 | Deerfield Imaging, Inc. IMRIS T2X Table, Part Number 109682-600 Terminated |
FQO | None listed |
| Feb 20, 2018 | Deerfield Imaging, Inc. IMRIS ORT100 Table, Part Number 110470-000 Terminated |
KXJ | None listed |
| Aug 14, 2017 | Deerfield Imaging IMRIS DEERFIELD IMAGING, REF 113803, Starburst adaptor thumb screw Terminated |
HBL | K103493 |
| Mar 11, 2016 | Deerfield Imaging Intra operative MRI Systems: Neuro II-SE , Neuro III-SV, iMRI 1.5T A, and iMRI 3T S.
Indicated for use as a magnetic resonance diagnostic device (MRDD). Terminated |
LNH | K061916 K071099 +2 |