510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Innovative Magnetic Resonance Imaging Systems, Inc.

Rockville, MD, US

Innovative Magnetic Resonance Imaging Systems, Inc. appears in FDA device records in Rockville, MD. FDA records list 2 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show one recall for this company.

FDA records held for this company

510(k) clearances
2
PMA records
0
Recall records
1
Registered establishments
0

510(k) clearance history

FDA records hold 2 510(k) clearances for Innovative Magnetic Resonance Imaging Systems, Inc. between 2000 and 2005. The busiest year on record is 2000, with 1. The most recent is 2005, with 1.

Clearances by year, as a table
510(k) clearance decisions for Innovative Magnetic Resonance Imaging Systems, Inc., by decision year
YearClearances
20001
20051
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K050132NEURO II-SLNHSubstantially Equivalent
K002964NEURO IILNHSubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-0428-2013IMRIS ORT100 (Part Number 110470-000) and ORT200 (Part Number 112216-00), are tables used in both the Neuro II-SE and Neuro III-SV Magnetic Resonance Imaging Systems.IMRIS Inc. initiated a recall of their OR Tables ORT100 and ORT200. When proper procedure is not followed, the foot end of the IMRIS intra-operative OR table may be attracted to the MRI magnet as the magnet approaches the table. This poses a potential risk of injury to both the patient and operators standing near the table.Class IITerminated

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Data as of , FDA export datePage updated Source: openFDA, public domain