510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Hermes Medical Solutions AB

Stockholm, SE

HERMES MEDICAL SOLUTIONS, AB appears in FDA device records in Stockholm, SE. FDA records list 17 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
17
PMA records
0
Recall records
1
Registered establishments
1

510(k) clearance history

FDA records hold 17 510(k) clearances for Hermes Medical Solutions AB between 2012 and 2026. The busiest year on record is 2017, with 4. The most recent is 2026, with 1.

Clearances by year, as a table
510(k) clearance decisions for Hermes Medical Solutions AB, by decision year
YearClearances
20121
20131
20142
20161
20174
20181
20191
20202
20241
20252
20261
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K253835AffinityQIHSubstantially Equivalent
K252477Hybrid Viewer (00859873006240)KPSSubstantially Equivalent
K243919Voxel Dosimetry (00859873006226)QIHSubstantially Equivalent
K241364Hybrid Viewer (00859873006189)KPSSubstantially Equivalent
K202882AffinityKPSSubstantially Equivalent
K193152AffinityKPSSubstantially Equivalent
K191216Voxel Dosimetry™ v1.0LLZSubstantially Equivalent
K181468Hybrid3DKPSSubstantially Equivalent
K171719Hybrid3DKPSSubstantially Equivalent
K171681Hermes Medical Imaging Suite v5.7KPSSubstantially Equivalent
K163687OLINDA EXMIYXSubstantially Equivalent
K163394Hybrid3DKPSSubstantially Equivalent
K153056Hermes Medical Imaging Suite v5.6KPSSubstantially Equivalent
K142631Hermes Medical Imaging Suite v5.5KPSSubstantially Equivalent
K140269HERMES MEDICAL IMAGING SUITE V5.4KPSSubstantially Equivalent
K131233HERMES MEDICAL IMAGING SUITE V5.3KPSSubstantially Equivalent
K121278HERMES MEDICAL IMAGING SUITE V5.2KPSSubstantially Equivalent

Registered establishments

FDA registered establishments for Hermes Medical Solutions AB, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
97106453002831423HERMES MEDICAL SOLUTIONS, ABStrandbergsgatan 16, STOCKHOLM SE-112 51 SE2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-0678-2025Hybrid Recon software on Hermes Medical Imaging Suite version 6.1 Hybrid Recon software versions affected are 4.0.0x and 5.0.0Due a potential software/configuration issue that may result is incorrect alignment during reconstructing a SPECT/CT study.Class IIOpen, Classified

Verification record

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