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.

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).

AI/ML Overview

The provided document is a 510(k) summary for the Philips PANORAMA 1.0T Magnetic Resonance Diagnostic Device. It claims substantial equivalence to a predicate device (INTERA ACHIEVA, K031815) and does not contain detailed performance studies with acceptance criteria as one would expect for a novel AI device.

Therefore, many of the requested fields cannot be filled as the information is not present in the provided text.

Here's a breakdown of the available information and why other fields cannot be completed:

Acceptance Criteria and Reported Device Performance: This device is a Magnetic Resonance Diagnostic Device (MRDD). For such devices, acceptance criteria are typically related to fundamental imaging performance aspects like signal-to-noise ratio (SNR), spatial resolution, image uniformity, geometric accuracy, and safety parameters (e.g., specific absorption rate (SAR), magnetic field homogeneity). However, the document does not provide specific quantitative acceptance criteria or reported device performance metrics for the PANORAMA 1.0T. It simply states that the new device "provides the same functionalities as its predicate device" and "has the same safety and effectiveness as its predicate device."
Study Details: Since this is a submission for a substantially equivalent device, clinical performance studies in the way you'd describe for a novel AI device (e.g., test set, expert readers, ground truth) are typically not presented in this summary document. The substantial equivalence argument relies on the inherent similarity of the new device to the predicate rather than new performance data.

Therefore, the table below will largely reflect what is not present or not applicable based on the provided text, along with a note that this is a predicate-based submission.

1. Table of Acceptance Criteria and Reported Device Performance

Criterion Description	Acceptance Criteria (Quantitative)	Reported Device Performance (Quantitative)	Explanation/Notes
Overall Performance/Equivalence	"Same safety and effectiveness as its predicate device" and "provides the same functionalities as its predicate device"	Not explicitly quantified in this document.	The core "acceptance" for this 510(k) is the demonstration of substantial equivalence to a legally marketed predicate device (cylindrical INTERA ACHIEVA, K031815). This means it is expected to perform comparably, but specific quantitative performance criteria for image quality metrics (like SNR, resolution, contrast) are not presented in this summary.

2. Sample size used for the test set and the data provenance:

Sample Size: Not applicable/Not provided. The submission is based on substantial equivalence to a predicate device, not a new clinical performance study.
Data Provenance: Not applicable/Not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable/Not provided. No new clinical performance study with expert ground truth was conducted or reported in this summary.

4. Adjudication method for the test set:

Not applicable/Not provided.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No. This is a conventional MRI device, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

No. This is a conventional MRI device.

7. The type of ground truth used:

Not applicable/Not provided. The submission relies on the established safety and effectiveness of the predicate device.

8. The sample size for the training set:

Not applicable/Not provided. This is a conventional MRI device, not an AI model requiring a training set in the typical sense.

9. How the ground truth for the training set was established:

Not applicable/Not provided.

Summary of the Study (as described in the document for the 510(k) submission):

The "study" or justification for the PANORAMA 1.0T's market clearance is a demonstration of substantial equivalence to an existing legally marketed device, the Philips INTERA ACHIEVA (K031815).

Study Design: This is not a clinical trial or performance study in the traditional sense for a novel device. Instead, it's a regulatory comparison.
Purpose: To demonstrate that the PANORAMA 1.0T, a Magnetic Resonance Diagnostic Device, is as safe and effective as its predicate device.
Methodology: The submission highlights that the PANORAMA 1.0T "provides the same functionalities as its predicate device" and "has the same safety and effectiveness." It is a magnetic resonance diagnostic device with a vertical field, similar to its predicate which used a cylindrical field (the document states it's based on the "same platform" as the cylindrical INTERA ACHIEVA). The primary justification is the inherent similarity in design, intended use, and fundamental operating principles.
Results: The FDA reviewed the 510(k) submission and determined that the device is "substantially equivalent" for the stated indications for use, thereby permitting its marketing. This implies that the FDA accepted the manufacturer's assertion that the performance characteristics, safety, and effectiveness would be comparable to the predicate device, without requiring new, specific quantitative performance data to be included in this summary.

Summary

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XJR-148-6269/bf

KOHINOOR

JUL 2 6 2004

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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 4-6Best, Netherlands, 5684 PC
Registration No.	:	1217116
Contact person	:	Joseph S. Arnaudo.Sr., Regulatory ManagerTel: (425) 482-8958Fax: (425) 487-8666Joseph 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 DiagnosticDevice Guidance, UL and IEC 601 appropriate safetystandards 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:

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Device description:

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

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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.

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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

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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

Regulation Number and Section

§ 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.