(42 days)
Not Found
No
The summary does not mention AI, ML, or any related concepts, and the device description focuses on standard MRI technology.
No
Explanation: The device is explicitly described as a "Magnetic Resonance Diagnostic Device" intended to "assist in diagnosis," not for therapy.
Yes
The text explicitly states "PANORAMA 1.0T is a Magnetic Resonance Diagnostic Device" in both the "Intended Use / Indications for Use" and "Device Description" sections. It also mentions that the images "may assist in diagnosis."
No
The device description explicitly states it is a magnetic resonance diagnostic device with hardware components like a magnet and a patient table, indicating it is not software-only.
Based on the provided information, the PANORAMA 1.0T is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's a "Magnetic Resonance Diagnostic Device intended for general diagnostic use that produces... images... that may assist in diagnosis." This describes an imaging device used to visualize internal structures of the body.
- Device Description: The description confirms it's a magnetic resonance device that uses a magnet and produces images.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) taken from the body to provide information about a person's health. The PANORAMA 1.0T directly images the body itself.
Therefore, the PANORAMA 1.0T falls under the category of medical imaging devices, not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
PANORAMA 1.0T is a Magnetic Resonance Diagnostic Device intended for general diagnostic use that produces transverse, sagittal, coronal and oblique crosssectional images based upon H metabolites, and that displays the internal structure of the whole body. These images when interpreted by a trained physician, yield information that may assist in diagnosis.
Product codes (comma separated list FDA assigned to the subject device)
LNH
Device Description
The PANORAMA 1.0T provides the same functionalities as its predicate device. It is a magnetic resonance diagnostic device with a vertical field. It uses a super conducting actively shielded magnet with a static field of 1.0 Tesla and a dockable wheeled patient table (couch).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Diagnostic Device
Anatomical Site
whole body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained physician
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
XJR-148-6269/bf
KOHINOOR
JUL 2 6 2004
Page 1 of 2
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
The following information is being submitted in accordance with the requirements of 21 CFR 807.92.
General information
| Company Name | : | Philips Medical Systems Nederland BV |
|---|---|---|
| Address | : | Veenpluis 4-6 |
| Best, Netherlands, 5684 PC | ||
| Registration No. | : | 1217116 |
| Contact person | : | Joseph S. Arnaudo. |
| Sr., Regulatory Manager | ||
| Tel: (425) 482-8958 | ||
| Fax: (425) 487-8666 | ||
| Joseph S. Arnaudo@Philips.com | ||
| Device (Trade) Name | : | PANORAMA 1.0T. |
| Classification Name | : | Magnetic Resonance Diagnostic Device (MRDD). |
| Classification | : | Class II. |
| Product code | : | LNH |
| Performance standards | : | NEMA voluntary standards, FDA MR Diagnostic |
| Device Guidance, UL and IEC 601 appropriate safety | ||
| standards and/or draft standards are used |
Predicate Device(s):
The PANORAMA 1.0T is a magnetic resonance diagnostic device with a vertical field based on the same platform as its predicate device cylindrical INTERA ACHIEVA (ref. K031815).
Indications for use:
PANORAMA 1.0T is a Magnetic Resonance Diagnostic Device intended for general diagnostic use that produces transverse, sagittal, coronal and oblique crosssectional images based upon H metabolites, and that displays the internal structure of the whole body. These images when interpreted by a trained physician, yield information that may assist in diagnosis.
1
Device description:
The PANORAMA 1.0T provides the same functionalities as its predicate device. It is a magnetic resonance diagnostic device with a vertical field. It uses a super conducting actively shielded magnet with a static field of 1.0 Tesla and a dockable wheeled patient table (couch).
General Safety and Effectiveness.
The PANORAMA 1.0T does not induce any other risks than already indicated for the predicate devices. It has the same safety and effectiveness as its predicate device.
Substantial Equivalence.
It is the opinion of Philips Medical Systems that the PANORAMA 1.0T is substantially equivalent to its predicate device.
End
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with three wavy lines representing the three levels of health services: direct care, environmental health, and preventive medicine. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 6 2004
Mr. Joseph S. Arnaudo Senior Regulatory Manager Philips Medical Systems North America 22100 Bothell Everett Highway BOTHELL WA 98021
Re: K041602
Trade/Device Name: PANORAMA 1.0T Regulatory Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II
Product Code: 90 LNH Dated: June 9, 2004 Received: June 14, 2004
Dear Mr. Arnaudo:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and probibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:
| 8xx. 1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brygdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page 1 of 1.
K041602 510(k) Number (if known):
Device Name :
PANORAMA 1.0T.
Indication For Use :
PANORAMA 1.0T is a Magnetic Resonance Diagnostic Device intended for general diagnostic use that produces transverse, sagittal, coronal and oblique crosssectional images based upon 'H metabolites, and that displays the internal structure of the whole body. These images when interpreted by a trained physician, yield information that may assist in diagnosis.
Prescription Use _ X (Per 21 CFR 801.109) OR Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
( PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C. Brogdon
(Division Sign Off)
(Optional Format 1-2-96)
(Division Sign Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number 1041602