510(k) Report

510(k) · Cleared

Cleared

Cirrus Open

K090080510(k) TraditionalCleared Mar 23, 200970-day reviewClass II21 CFR 892.1000

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Mri-Tech Sp. Zo.O. · LNH System, Nuclear Magnetic Resonance Imaging

Cleared on Mar 23, 2009 as substantially equivalent to K992135 (Ge Medical Systems, Inc., 1999) and 1 other predicate after a 70-day review. Its family tree reaches back 1 generation to 1998.

Decided
Mar 23, 2009
Review
70 days
Class
Class II
Product code
LNH
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K974212 (1998). 2 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1999: 1 other ancestorK974212 · Airis II · Hitachi Medical Systems America, Inc. · 1998 · recalled1995200020052010
Other ancestors, by generation 1 generation back: 1 other ancestor K974212 · Airis II · Hitachi Medical Systems America, Inc. · 1998 · recalled0
  1. Root · 1 generation backK974212 Airis IIHitachi Medical Systems America, Inc. · 1998 · Recalled
  2. This deviceK090080 Cirrus OpenMri-Tech Sp. Zo.O. · 2009
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K974212Airis IIHitachi Medical Systems America, Inc.19985
0 (this device)K090080Cirrus OpenMri-Tech Sp. Zo.O.2009—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199910
FIG. 1 — Lineage of K090080, 1998–2009Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in LNH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new LNH device

  1. #1 K213693 MAGNETOM Vida with syngo MR XA50Ascore 23.0 · 18 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against? (2)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K992135Signa Profile/I Magnetic Resonance System
Summary page 1
…e Name: CIRRUS OPEN Magnetic Resonance Diagnostic Device, 21 CFR 892.1000, 90-LNH, Class II Predicate Device(s): Device Name: GE SIGNA PROFILE 0.2 T (GE Signa Profile/i K992135) Manufacturer/Submitter: GE MEDICAL SYSTEMS Device Name: AIRIS MATE (Airis II K974212) Manufacturer/Submitter: HITACHI MEDICAL S…
Ge Medical Systems, Inc.1999—
*K974212Airis II
Summary page 1
…s II Predicate Device(s): Device Name: GE SIGNA PROFILE 0.2 T (GE Signa Profile/i K992135) Manufacturer/Submitter: GE MEDICAL SYSTEMS Device Name: AIRIS MATE (Airis II K974212) Manufacturer/Submitter: HITACHI MEDICAL SYSTEMS…
Hitachi Medical Systems America, Inc.19985

Also cleared against K992135: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • 1 of the 2 ancestors has a recall of any class.
  • 1 other device also cites its predicate K992135.

How does its category compare?

All LNH devices

LNH System, Nuclear Magnetic Resonance Imaging: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · LNH

26in 2025

2007: 122008: 192009: 172010: 122011: 162012: 222013: 192014: 172015: 192016: 202017: 182018: 292019: 262020: 322021: 272022: 302023: 302024: 262025: 262026 (partial year): 24
2007high 32 (2020) · low 12 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LNH

122in 2025

2007: 35 days median2008: 53 days median2009: 70 days median2010: 94 days median2011: 81 days median2012: 89 days median2013: 108 days median2014: 108 days median2015: 140 days median2016: 108 days median2017: 98 days median2018: 128 days median2019: 62 days median2020: 121 days median2021: 87 days median2022: 74 days median2023: 124 days median2024: 104 days median2025: 122 days median2026 (partial year): 126 days median
2007high 140 (2015) · low 35 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LNH

8in 2025

2007: 252008: 122009: 72010: 172011: 112012: 52013: 22014: 132015: 12, 2 Class I2016: 12018: 712019: 52020: 42021: 412022: 132023: 10, 1 Class I2024: 42025: 8, 5 Class I2026 (partial year): 43
2007high 71 (2018) · low 0 (2017)2026

Class I (8 since 2007) Class II/III not classified

Adverse event reports per year · LNH

1,263in 2025

2007: 1142008: 1672009: 1942010: 1652011: 1822012: 1702013: 1072014: 1192015: 1132016: 1352017: 1212018: 1582019: 1582020: 982021: 842022: 1382023: 1592024: 2812025: 1,263
2007high 1,263 (2025) · low 84 (2021)2025

MAUDE reports naming product code LNH, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007123525114
2008195312167
200917707194
2010129417165
2011168111182
201222895170
2013191082107
20141710813119
20151914012 (2)113
2016201081135
201718980121
20182912871158
201926625158
202032121498
202127874184
2022307413138
20233012410 (1)159
2024261044281
2025261228 (5)1,263
20262412643—

What is it indicated for?

Cirrus Open is an open, 0.2 Tesla MR imaging device intended to provide a physician with physiological and clinical information obtained non-invasively using magnetic resonance imaging (MRI) without the use of ionizing radiation. Cirrus Open is indicated for use as a diagnostic imaging device to produce images in the transverse, sagittal, coronal and oblique scan planes of a patient's head. The images produced by Cirrus Open reflect the spatial…

Read the full statement (125 words)

Cirrus Open is an open, 0.2 Tesla MR imaging device intended to provide a physician with physiological and clinical information obtained non-invasively using magnetic resonance imaging (MRI) without the use of ionizing radiation. Cirrus Open is indicated for use as a diagnostic imaging device to produce images in the transverse, sagittal, coronal and oblique scan planes of a patient's head. The images produced by Cirrus Open reflect the spatial distribution of protons (hydrogen nuclei). The magnetic properties that determine the appearance of images are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2) and T2* relaxation time. Additional contrasts that can be used include magnetization transfer and diffusion. When interpreted by a trained physician, these images provide information that can be useful in diagnosis.

Indications for use as stated in the FDA summary.

Also cleared against K992135

1 other device cites the same predicate.

  • K033168GE 0.2T Signa Profile/I MR SystemGeneral Electric Co. · 2003

Recent decisions in LNH

The LNH category page

  • K262902ECHELON SynergyFujifilm Corporation · 2026
  • K260092Vista AI ScanVista AI, Inc. · 2026
  • K261612SwiftSight-BodyCompositionAirs Medical, Inc. · 2026
  • K261283APERTO Lucent MRI SystemFujifilm Corporation · 2026
  • K261758Embrace Vision Neonatal MRI SystemAspect Imaging, Ltd. · 2026

https://510kreport.com/device/K090080 · printed Nov 6, 2026

Cite this page

510(k) Report. “K090080: Cirrus Open.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090080

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026