(21 days)
Not Found
No
The summary describes a conventional x-ray system with a new exposure control system (DEC) replacing an older one (AEC). There is no mention of AI, ML, training data, test data, or performance metrics typically associated with AI/ML devices. The "image manipulation" mentioned is a standard feature of digital imaging systems and does not imply AI/ML.
No
The device is an x-ray imaging system intended for diagnostic examination, not for treating diseases or conditions.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is "intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures."
No
The device description clearly states it is an "extraoral source x-ray system" and a "conventional panoramic x-ray system," indicating it includes hardware components for generating and capturing x-ray images. While it mentions digital imaging and image manipulation via a computer, the core device is a hardware system.
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 Planmeca Promax is an extraoral source x-ray system. It uses X-rays to create images of the teeth, jaw, and oral structures. This is an imaging device, not a device that analyzes biological samples.
- Intended Use: The intended use is for "dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures." This involves capturing images for visual interpretation by a healthcare professional, not performing tests on biological specimens.
Therefore, the Planmeca Promax falls under the category of medical imaging devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
Planmeca Promax, panoramic x-ray imaging system with cephalostat, is an extraoral source x-ray system, which is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The device can be equipped with accessories to fulfil the technical requirements related to different diagnostic needs. In digital configuration the images are displayed on a monitor, and image manipulation, archiving and communication are performed via a computer.
Product codes
EHD, MUH
Device Description
Planmeca Promax is a conventional panoramic x-ray system utilizing either films and cassettes or a digital imaging system. The product can be equipped with a cephalostat. The product modification includes a new DEC (Dynamic Exposure Control) system, which is designed to be used in digital imaging, in both panoramic and cephalostat modes, and replaces the old AEC system used.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray
Anatomical Site
teeth, jaw, and oral structures
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
Not Found
§ 872.1800 Extraoral source x-ray system.
(a)
Identification. An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the text "K051464" in a handwritten style. The text is written in black ink on a white background. The numbers are slightly distorted, giving the text a unique and informal appearance.
Image /page/0/Picture/1 description: The image shows the word PLANMECA in large, bold, white letters against a black background. Below PLANMECA, the words ENCLOSURE 12 are written in a smaller, serif font. Underneath that, the text "P. 12-1" is displayed, indicating a page number or reference within the enclosure.
510K) SUMMARY
DATE
May 27, 2005
PRODUCT, CLASSIFICATION NAME
Trade name: Planmeca Promax Common name: Panoramic x-ray system with cephalostat Classification: 76 EHD, Class II Regulation number: 872.1800
MANUFACTURER
Planmeca Oy Asentajankatu 6 FI-00880 Helsinki, Finland Phone: +358 20 7795 500 Fax: +358 20 7795 396 Contact person: Lars Moring
UNITED STATES SALES REPRESENTATIVE (U.S. DESIGNATED AGENT)
Planmeca USA Inc. 100 North Gary Avenue, Suite A Roselle, IL 60172 Phone: (630) 529 2300 Fax: (630) 529 1929 Contact person : Bob Pienkowski
INTENDED USE
Planmeca Promax, panoramic x-ray imaging system with cephalostat, is an extraoral source x-I lanneca I romax, panorame it to dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The device can be equipped with accessories to fulfil the techt, jaw, and oftretration the images are displayed on a monitor, and image manipulation, archiving and communication are performed via a computer.
PRODUCT DESCRIPTION
I KODOCT DESORT is a conventional panoramic x-ray system utilizing either films and r he I hanneed I rollian is g. The product can be equipped with a cephalostat. The product modification includes a new DEC (Dynamic Exposure Control) system, which is designed to be used in digital imaging, in both panoramic and cephalostat modes, and replaces the old AEC system used.
1
SUBSTANTIAL EQUIVALENCE
SUBSTANTIAL EQUI PALEACE
We consider this product modification including a new DEC (Dynamic Exposure Control) we consider in sproduce mountion ition and function to the following devices introduced into commercial distribution after May 28, 1976:
Planmeca Promax # K011619 PM 2002 Proline with AEC # K000163
The comparison of characteristics supports substantial equivalence. Planmeca Promax with DEC is as safe and effective as the predicate devices.
2
Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. The bottom half of the circle contains a stylized image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Bob Pienkowski Managing Director Planmeca USA, Inc. 100 North Gary Avenue, Suite A ROSELLE IL 60172
Re: K051464
.
JUN 2 4 2005
Trade/Device Name: Planmeca Promax with DEC (Dynamic Exposure Control) Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: EHD and MUH Dated: May 27, 2005 Received: June 3, 2005
Dear Mr. Pienkowski:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced in we have reviewed your Section 910(t) proisentially equivalent (for the indications for use stated in above and have decemined the device is accessions of the enclosure) to tegally marketed predisate active in to devices that have been the Arthur May 26, 1970, the enactificant and of the Federal Food, Drug, and Cosmetic Act (Act (Act (Act (Act (Act (Act (Act (Act (Act (Act (Act (Act (Act (Act (Act (Act (Act reclassified in accordance with the proval application (PMA). You may, therefore, market the do not require approval of a premaince approval septimation (The general controls provisions of the Act
device, subject to the general controls provisions of the Act. The ge device, subject to the general controls provisions 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 If your device is classified (300 additional controls. Existing major regulations affecting your Apploval), it they of subject to back aderal Regulations, Title 21, Parts 800 to 898. In addition, FDA device can be found in the Sourcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FIEASE be advised that I DX 3 issumited on aevice complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Federal statucs and regulations administration and listing (21 CFR Part 807); labeling Act s requirements, medading, but not minted to requirements as set forth in the quality systems (QS) (21 CFR Part 801); 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 5 10(k)
10 1 leggly of the first of a first of a location international of your device This letter will anow you to begin maneting your antial equivalence of your device to a legally premarket notification. The FDA miding of saosantial or 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), pleased If you desire specific advice for your device of our may beging 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 premated notification" (21 CFR Also, please note the regulation entities; "Firstenant on your responsibilities under the Act from the 807.97). You may obtain other general 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
Planmeca Oy 510(k) Notification Planmeca Promax with DEC
INDICATIONS FOR USE
Planmeca Promax, panoramic x-ray imaging system with Cephalostat, is an extraoral source xand the survey and and sected as the counting and diagnosis of diseases of Planneca Promax, panoramic x-ray magnic examination and disensis of diseases of
ray system, which is intended for and radiographic examination and diseases of
eray system, wh ray system, which is intended for deltar ractorial with accessories to fulfil the teeth, jaw, and oral structures. The active can overspeared isplayed on a monitor, and
different diagnostic needs. In digital configuration the scomputer different diagnostic needs. In digital connigulation are performed via a computer.
image manipulation, archiving and communication are performed via a computer.
Helsinki, May 27, 2005
Luis le Roy
Lars Moring Regulatory Affairs Managel Planmeca Oy
Prescription Use ✓
Nancy Brogdon
(Division Sign-Off) Division of Reproductive, Abdo and Radiological Devices 510(k) Number