(7 days)
Not Found
No
The summary describes a standard MRI system upgrade with improved gradient configurations, focusing on hardware performance enhancements (slew rate, TE, ES, TR). There is no mention of AI, ML, or any related concepts in the intended use, device description, or specific sections for AI/ML details.
No
The "Intended Use / Indications for Use" section explicitly states that the devices are "diagnostic devices" and their purpose is to "assist in diagnosis," not treatment or therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states, "ACHIEVA 1.5T & INTERA 1.5T family consists of diagnostic devices."
No
The device description explicitly mentions "hardware technology" and "MR system parts," indicating it is a hardware-based medical device with associated software, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as producing images and spectra of the internal structure of the body to assist in diagnosis when interpreted by a trained physician. This is characteristic of an in-vivo diagnostic imaging device, not an in-vitro diagnostic device.
- Device Description: The description details a Magnetic Resonance (MR) system, which is a type of medical imaging equipment used to visualize internal body structures. IVD devices typically involve testing samples (like blood, urine, or tissue) outside of the body.
- Input Imaging Modality: The input modality is Magnetic Resonance, which is an in-vivo imaging technique.
- Anatomical Site: The device is used on the "whole body," indicating direct interaction with the patient, not a sample.
IVD devices are designed to perform tests on biological samples taken from the body to provide information about a person's health. This device, an MR system, directly images the body itself.
N/A
Intended Use / Indications for Use
The ACHIEVA 1.5T & INTERA 1.5T consists of diagnostic devices that produce crosssectional images, spectroscopy images and/or spectra in any orientation of the internal structure of the whole body. These images when interpreted by a trained physician yield information that may assist in diagnosis.
ACHIEVA 1.5 & INTERA 1.5T family consists of diagnostic devices that produce cross-sectional images, spectroscopy images and/or spectra in any orientation of the internal structure of the whole body. These images when interpreted by a trained physician, yield information that may assist in diagnosis
Product codes
LNH
Device Description
The ACHIEVA 1.5T & INTERA 1.5T family is the successor of the predicate ACHIEVA family release 1-series.
The design of ACHIEVA 1.5T & INTERA 1.5T family is based on the same software platform and hardware technology as its predicate device. All MR system parts of the ACHIEVA 1.5T & INTERA 1.5T family have the same appearance.
The new gradient configurations are more powerful than their previous versions available on the Intera 1.5T and Achieva 1.5T systems. Especially the slewrate of these systems is improved. This improved slewrate allows for shorter echo times (TE), Echo Spacing (ES) and repetition times (TR).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance (MR)
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
AUG 2 - 2005
APPENDIX Va
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: | Lynn Harmer |
| Manager, regulatory Submissions | |
| Tel: (425) 487-7312 | |
| Fax: (425) 487-8666 | |
| Lynn.Harmer@Philips.com | |
| Date Prepared: | July 12, 2005 |
| Device (Trade) Name: | ACHIEVA 1.5T & INTERA 1.5T family |
| Classification Name: | Magnetic Resonance Diagnostic Device (MRDD) |
| Regulatory Number: | 892.1000 |
| 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 Philips Medical Systems ACHIEVA 1.5T & INTERA 1.5T are the successors of the already cleared (predicate device) ACHIEVA family release 1-series (ref. K043147).
Indications for use:
The ACHIEVA 1.5T & INTERA 1.5T consists of diagnostic devices that produce crosssectional images, spectroscopy images and/or spectra in any orientation of 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 ACHIEVA 1.5T & INTERA 1.5T family is the successor of the predicate ACHIEVA family release 1-series.
The design of ACHIEVA 1.5T & INTERA 1.5T family is based on the same software platform and hardware technology as its predicate device. All MR system parts of the ACHIEVA 1.5T & INTERA 1.5T family have the same appearance.
The new gradient configurations are more powerful than their previous versions available on the Intera 1.5T and Achieva 1.5T systems. Especially the slewrate of these systems is improved. This improved slewrate allows for shorter echo times (TE), Echo Spacing (ES) and repetition times (TR).
General Safety and Effectiveness
The ACHIEVA 1.5T & INTERA 1.5T family does not induce any other risks than already indicated for its predicate device with the same safety and effectiveness.
Substantial Equivalence
It is the opinion of Philips Medical Systems that the Philips ACHIEVA 1.5T & INTERA 1.5T family is substantially equivalent to its predicate device ACHIEVA family.
End
2
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. In the center of the seal is a stylized image of a bird, possibly an eagle, with three lines representing its wings or feathers.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Philips Medical Systems Nederland BV % Mr. Marc M. Mouser Senior Project Engineer/Reviewer UL Conformity Assessment Services Underwriters Laboratories, Inc. West Coast Division, Camas Office 2600 N.W. Lake Road CAMAS WA 98607-8542
Re: K052013
AUG 2 - 2005
Trade/Device Name: Achieva 1.5T & Intera 1.5T Family Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: July 22, 2005
Received: July 26, 2005
Dear Mr. Mouser:
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 prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), 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
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 this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
APPENDIX Vb
Indication for use
510(k) Number (if known):
1052013
Device Name:
ACHIEVA 1.5T & INTERA 1.5T family
Indication For Use:
ACHIEVA 1.5 & INTERA 1.5T family consists of diagnostic devices that produce cross-sectional images, spectroscopy images and/or spectra in any orientation of 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 brogelon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K052013