(79 days)
No
The device description focuses on the mechanical aspects of a patient couch and its compatibility with existing imaging systems. There is no mention of AI, ML, or any software-driven analytical capabilities.
No
The device is described as an add-on couch for an MRI system, enabling patient transfer and transport to other imaging modalities. Its function is to facilitate imaging, not to provide therapy.
No
The device is described as an "Add-on Couch" that augments patient handling for MRI and X-ray systems. Its purpose is to facilitate patient transfer and positioning for imaging, not to perform diagnostic analysis itself. It allows for "MR imaging" and "fluoroscopic examinations," which are diagnostic procedures, but the couch is a support device for these procedures, not the diagnostic device itself.
No
The device description clearly details physical components like a couch, base, and materials (bakelite, PVC-foam, aluminum), indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Movable Add-on Couch is a piece of equipment designed to facilitate patient handling and positioning during medical imaging procedures (MRI and X-Ray). It does not perform any tests on biological samples.
- Intended Use: The intended use is for patient positioning and transfer during imaging, not for analyzing biological specimens.
The device is a medical device, specifically a patient support and transfer system used in conjunction with imaging equipment.
N/A
Intended Use / Indications for Use
The Movable Add-on Couch is designed to be used with the Outlook MRI system and in an X-Ray environment. The indications for use are the same as for standard MR imaging.
Product codes
Not Found
Device Description
The Movable Add-on couch augments the patient handling capabilities of the Outlook MRI system. It interfaces directly with the Outlook patient couch.
The Movable Add-on Couch enables transfer of the patient together with the upper couch plate to and from a movable base directly into the Outlook patient handling system. This makes it possible to do MR imaging without having to lift patient from the supporting surface. The patient can be transported to other imaging modalities using the movable base.
The movable couch also has a radio-translucent upper part making it possible to do fluoroscopic examinations, e.g. with an X-Ray C-arm system, of the patient while on the couch.
The upper couch plate is made of sandwiched bakelite/PVC-foam material. The movable base has two parts; the X-Ray transparent part made of bakelite and the load-carrying parts and coMwrs made of aluminum.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MR and X-Ray
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
Not Found
§ 892.1000 Magnetic resonance diagnostic device.
(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
SUMMARY OF SAFETY AND EFFECTIVENESS
| 1. | General Information | MAY 29 1996 | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Classification: | Class II | |||||||||||||||
| Magnetic Resonance (MR) Imaging System | ||||||||||||||||
| Common/Usual Name: | MRI Patient Couch | |||||||||||||||
| Proprietary Name: | Movable Add-on Couch for Outlook | |||||||||||||||
| Establishment Registration: | Manufacturer: | |||||||||||||||
| Picker Nordstar, Inc. | ||||||||||||||||
| P.O. Box 33 | ||||||||||||||||
| FIN-0051 Helsinki, FINLAND | ||||||||||||||||
| Phone: +358-0-394 127 | ||||||||||||||||
| Fax: +358-0-146 2811 | ||||||||||||||||
| FDA Facility Registration #9680194 | ||||||||||||||||
| United States Representative: | ||||||||||||||||
| Picker International, Inc. | ||||||||||||||||
| 595 Miner Road | ||||||||||||||||
| Cleveland, OH 44143 | ||||||||||||||||
| FDA Owner Number #1580240 | ||||||||||||||||
| Performance Standards: | No applicable performance standards have been issued under section 514 of the Food, Drug and Cosmetic Act. The device and its labeling comply with the following applicable requirements. | |||||||||||||||
| Code of Federal Regulations Title 21, Subchapter J - Radiological Health, applicable sections which include: 1020.30(c)Certification of components1020.30(e)Identification of X-ray components1020.30(g)Information for assemblers1020.30(h)Information for users1020.30(n)Aluminum equivalent of material1020.31(3)(1)(i)Beam axis perpendicularity to image receptor and SID | 1020.30(c) | Certification of components | 1020.30(e) | Identification of X-ray components | 1020.30(g) | Information for assemblers | 1020.30(h) | Information for users | 1020.30(n) | Aluminum equivalent of material | 1020.31(3)(1)(i) | Beam axis perpendicularity to image receptor and SID | ||||
| 1020.30(c) | Certification of components | |||||||||||||||
| 1020.30(e) | Identification of X-ray components | |||||||||||||||
| 1020.30(g) | Information for assemblers | |||||||||||||||
| 1020.30(h) | Information for users | |||||||||||||||
| 1020.30(n) | Aluminum equivalent of material | |||||||||||||||
| 1020.31(3)(1)(i) | Beam axis perpendicularity to image receptor and SID | |||||||||||||||
| PICKER INTERNATIONAL, INC. | (MCO) | (3/7/96) | I-1 |
)
(3/7/96)
1
2. Intended Uses
The Movable Add-on Couch is designed to be used with the Outlook MRI system and in an X-Ray environment. The indications for use are the same as for standard MR imaging.
3. Device Description
The Movable Add-on couch augments the patient handling capabilities of the Outlook MRI system. It interfaces directly with the Outlook patient couch.
The Movable Add-on Couch enables transfer of the patient together with the upper couch plate to and from a movable base directly into the Outlook patient handling system. This makes it possible to do MR imaging without having to lift patient from the supporting surface. The patient can be transported to other imaging modalities using the movable base.
The movable couch also has a radio-translucent upper part making it possible to do fluoroscopic examinations, e.g. with an X-Ray C-arm system, of the patient while on the couch.
The upper couch plate is made of sandwiched bakelite/PVC-foam material. The movable base has two parts; the X-Ray transparent part made of bakelite and the load-carrying parts and coMwrs made of aluminum.
Safety and Effectiveness 4.
SUBSTANTIAL EQUIVALENCE CHART
| PARAMETER | MOVABLE ADD-ON COUCH
FOR OUTLOOK | PREDICATE |
|------------------------------------|-------------------------------------|-----------------------------------------------|
| Length | 2400 mm | 2400 mm |
| Width of couch plate | 625 mm (+ handle 55mm) | 625 mm |
| Height to the edge of the
couch | 880 mm (upper
position) | 880 mm
(Outlook standard couch
K945827) |
| Portable | yes | no (Outlook standard
couch K945827) |
I-2
PICKER INTERNATIONAL, INC. (MCO) (3/7/96)
2
| PARAMETER | MOVABLE ADD-ON COUCH
FOR OUTLOOK | PREDICATE |
|------------------------|---------------------------------------|--------------------------------------------------------------------|
| Maximum patient weight | 200 kg | 200 kg (Outlook standard couch
K945827) |
| Movement, horizontal | manual | manual (Outlook standard
couch K945827) |
| Movement, vertical | motorized, battery powered | no (Outlook standard couch
K945827) |
| X-Ray Absorption | equal to or below 1.5 mm
aluminum | rejection limit 1.2 mm (NRF X-
Ray Table K944973) |
| Intended for Use | MR and X-Ray examinations;
movable | MR examinations; stationary
(Outlook standard couch
K945827) |
PICKER INTERNATIONAL, INC. (MCO)
f
(3/8/96)
I-3