510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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NRT X-Ray a/S

HASSELAGER Midtjylland, DK

NRT X-RAY A/S appears in FDA device records in HASSELAGER Midtjylland, DK. FDA records list 3 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 5 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
3
PMA records
0
Recall records
5
Registered establishments
1

FDA records under these names

1 name

FDA records resolved to NRT X-Ray a/S carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

  • Nrt-Nordisk Rontgen Teknik A/S510(k), recall

510(k) clearance history

FDA records hold 3 510(k) clearances for NRT X-Ray a/S between 2003 and 2024. The busiest year on record is 2003, with 1. The most recent is 2024, with 1.

Clearances by year, as a table
510(k) clearance decisions for NRT X-Ray a/S, by decision year
YearClearances
20031
20181
20241
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K242948Adora DRFi (04550010)JAASubstantially Equivalent
K173631Intelli-COWBSubstantially Equivalent
K033486GE PRECISION MPIOWBSubstantially Equivalent

Registered establishments

FDA registered establishments for NRT X-Ray a/S, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
10001884741000188474NRT X-RAY A/SBIRKEGAARDSVEJ 16, HASSELAGER Midtjylland 8361 DK2026

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-1784-2024Intelli-C: Right side suspended Tabletop, REF: 03400000; Left side suspended Tabletop, REF: 03400010, used with the Intelli-C X-ray systemX-ray system C-arm may experience uncontrolled motion if 1) AC motor controller firmware has a faulty setting, 2) the Motor/gear assembly is worn, 3) CAT movement is driven at maximum speed and angulated more than 75 deg. from vertical, and 4) the emergency stop or touch guard is activated during the breaking sequence, which could lead to the C-arm hitting the patient or operator.Class IIOpen, Classified
Z-1669-2023Intelli-C, Left side suspended Tabletop, REF: 03400010There is a potential that the drive shaft in the detector up/down (IDE) movement of the X-Ray machine may break which causes the detector to move until it is stopped by the movement end-stop.Class IIOpen, Classified
Z-1668-2023Intelli-C, Right side suspended Tabletop, REF: 03400000There is a potential that the drive shaft in the detector up/down (IDE) movement of the X-Ray machine may break which causes the detector to move until it is stopped by the movement end-stop.Class IIOpen, Classified
Z-0526-20221. Footrest ( use exclusively in combination with Intelli-C devices) 2. Shoulder support ( use exclusively in combination with Intelli-C devices)Friction rubber block in the clamping mechanism was missing in the Footrest. It may slip down along the patient table while in use with a patient. This accessory is designed to use with Intelli-C, Right and Intelli-C, Left.Class IIOpen, Classified
Z-1658-2009Celex/GE Precision MPi, REF no.: 02980000 Is an all-digital multipurpose tilt-C X-ray system, intended for a multitude of diagnostic procedures, including: R&F, radiology, fluoroscopy, interventional procedures, vascular and non-vascular procedures, and specialized applications including angiographic studies.The GE Precision MPi is in violation with 21 CFR Part 1020.32 requiring a signal audible to the fluoroscopist to sound for each passage of 5 minutes of fluoroscopic irradiation time during an examination or procedure.Terminated

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